Diet ( DrugBank: - )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 86 | 肺動脈性肺高血圧症 | 67 |
| 97 | 潰瘍性大腸炎 | 72 |
| 240 | フェニルケトン尿症 | 35 |
| 299 | 嚢胞性線維症 | 47 |
86. 肺動脈性肺高血圧症
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04908397 (ClinicalTrials.gov) | September 29, 2021 | 17/5/2021 | Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension | Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension;Primary Pulmonary Hypertension;Lung Diseases;Carnitine Nutritional Deficiency | Dietary Supplement: L-carnitine | Vanderbilt University Medical Center | NULL | Recruiting | 18 Years | 85 Years | All | 12 | Phase 1 | United States |
| 2 | NCT05318950 (ClinicalTrials.gov) | October 20, 2019 | 10/12/2021 | A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon | A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon: Effect on quaLity of Life | Pulmonary Arterial Hypertension | Behavioral: E-learning;Dietary Supplement: Diet | Amsterdam UMC, location VUmc | Reinier de Graaf Groep;Janssen-Cilag B.V. | Completed | 18 Years | 80 Years | All | 40 | N/A | Netherlands |
| 3 | EUCTR2012-000098-21-PL (EUCTR) | 27/02/2016 | 20/01/2016 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of;Greece;United States;Taiwan | ||
| 4 | EUCTR2012-000097-26-PL (EUCTR) | 27/02/2016 | 20/01/2016 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | Israel;Chile;Italy;United Kingdom;India;United States;Taiwan;Greece;Austria;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 5 | EUCTR2012-000098-21-FR (EUCTR) | 24/11/2015 | 26/09/2012 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 15.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 858 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 6 | EUCTR2012-000097-26-GR (EUCTR) | 05/08/2014 | 11/06/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 858 | Phase 3 | France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden;United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;India | ||
| 7 | EUCTR2012-000098-21-GR (EUCTR) | 05/08/2014 | 10/06/2014 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 858 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 8 | EUCTR2012-000097-26-DK (EUCTR) | 31/07/2014 | 22/05/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 9 | EUCTR2012-000098-21-DK (EUCTR) | 31/07/2014 | 22/05/2014 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 10 | EUCTR2012-000097-26-BE (EUCTR) | 18/06/2014 | 14/04/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 858 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 11 | EUCTR2012-000098-21-BE (EUCTR) | 18/06/2014 | 14/04/2014 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 858 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 12 | EUCTR2012-000097-26-SE (EUCTR) | 09/06/2014 | 10/04/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 13 | EUCTR2012-000098-21-SE (EUCTR) | 15/05/2014 | 10/04/2014 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 14 | NCT02000856 (ClinicalTrials.gov) | November 2013 | 19/11/2013 | BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension | BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: Beetroot juice | Uppsala University | Karolinska Institutet | Completed | 18 Years | N/A | All | 15 | N/A | Sweden |
| 15 | NCT01934582 (ClinicalTrials.gov) | August 2013 | 29/8/2013 | A Pharmacokinetic Substudy of the TDE-PH-304 Protocol | A Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 Protocol | Pulmonary Arterial Hypertension | Drug: UT-15C SR;Drug: treprostinil diethanolamine | United Therapeutics | NULL | Completed | 12 Years | 75 Years | All | 13 | Phase 3 | United States |
| 16 | EUCTR2012-000097-26-IT (EUCTR) | 22/05/2013 | 19/12/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 17 | EUCTR2012-000098-21-IT (EUCTR) | 22/05/2013 | 11/01/2013 | An Open Label Extension Study of UT-15C in subjects with PulmonaryArterial Hypertension | An Open Label Extension Study of UT-15C in subjects with PulmonaryArterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C Product Name: treprostinil diethanolamine Product Code: UT-15C Product Name: treprostinil diethanolamine Product Code: UT-15C Product Name: treprostinil diethanolamine Product Code: UT-15C Product Name: treprostinil diethanolamine Product Code: UT-15C | UNITED THERAPEUTICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 858 | United States;Taiwan;Austria;Israel;Italy;United Kingdom;Mexico;Canada;Brazil;Australia;Germany;Netherlands;Korea, Republic of | |||
| 18 | EUCTR2012-000098-21-NL (EUCTR) | 05/03/2013 | 10/08/2012 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Germany;Netherlands;China;Sweden;Korea, Republic of | ||
| 19 | EUCTR2012-000097-26-NL (EUCTR) | 18/02/2013 | 29/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Germany;Netherlands;China;Korea, Republic of;Sweden | ||
| 20 | EUCTR2012-000098-21-DE (EUCTR) | 14/11/2012 | 01/08/2012 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 21 | EUCTR2012-000098-21-GB (EUCTR) | 06/11/2012 | 01/08/2012 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 850 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 22 | EUCTR2012-000097-26-GB (EUCTR) | 06/11/2012 | 01/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 23 | EUCTR2012-000098-21-AT (EUCTR) | 18/10/2012 | 07/09/2012 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 24 | EUCTR2012-000097-26-AT (EUCTR) | 21/09/2012 | 07/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension receiving background oral monotherapy | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 25 | EUCTR2012-000097-26-DE (EUCTR) | 17/09/2012 | 02/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receivingbackground oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 26 | NCT01560637 (ClinicalTrials.gov) | May 2012 | 9/3/2012 | An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension | Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310 | Pulmonary Arterial Hypertension | Drug: UT-15C (treprostinil diethanolamine) | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 471 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom |
| 27 | NCT01446848 (ClinicalTrials.gov) | January 2012 | 3/10/2011 | Oral Iron Supplementation in Pulmonary Hypertension | Oral Iron Supplementation in Pulmonary Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: iron supplement | The Cleveland Clinic | NULL | Completed | 21 Years | N/A | Both | 6 | N/A | United States |
| 28 | NCT01172496 (ClinicalTrials.gov) | August 2010 | 28/7/2010 | A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy Volunteers | A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral Solution in Healthy Volunteers | Pulmonary Arterial Hypertension | Drug: treprostinil diethanolamine | United Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 24 | Phase 1 | United States |
| 29 | EUCTR2006-000804-18-PT (EUCTR) | 02/07/2010 | 25/01/2010 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Portugal;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 30 | NCT01153386 (ClinicalTrials.gov) | July 2010 | 28/6/2010 | Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine | An Evaluation of the Pharmacokinetic Linearity and Comparative Bioavailability of a Single Oral Dose of 0.5 mg, 1 mg and 2.5 mg UT-15C (Treprostinil Diethanolamine) SR Tablets in Healthy Volunteers in the Fed State | Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine | United Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 36 | Phase 1 | United States |
| 31 | NCT01165476 (ClinicalTrials.gov) | July 2010 | 15/7/2010 | Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities | An Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed State | Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine | United Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 64 | Phase 1 | United States |
| 32 | NCT01131845 (ClinicalTrials.gov) | May 2010 | 10/5/2010 | The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil | An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment. | Pulmonary Arterial Hypertension;Renal Dysfunction | Drug: UT-15C SR (treprostinil diethanolamine) | United Therapeutics | NULL | Completed | 18 Years | 79 Years | Both | 16 | Phase 1 | United States |
| 33 | EUCTR2009-009366-13-PT (EUCTR) | 05/03/2010 | 03/11/2009 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 34 | EUCTR2006-000804-18-SE (EUCTR) | 28/01/2010 | 03/12/2009 | An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden | ||
| 35 | NCT01148836 (ClinicalTrials.gov) | January 2010 | 19/3/2010 | Coenzyme Q-10 and Pulmonary Arterial Hypertension | Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects;Dietary Supplement: Coenzyme Q-10 in Normal Control subjects | The Cleveland Clinic | NULL | Completed | 18 Years | 55 Years | All | 18 | N/A | United States |
| 36 | EUCTR2009-009366-13-SE (EUCTR) | 17/12/2009 | 22/10/2009 | A study to assess how safe and effective an oral UT-15C tablet is when given to subjects with high blood pressure in the artery that carries blood to the lungs | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Germany;Netherlands;France;Italy;Austria;Sweden;Israel;United Kingdom;Mexico;Belgium;Puerto Rico;Spain | |||
| 37 | EUCTR2009-009366-13-FR (EUCTR) | 26/11/2009 | 06/11/2009 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Portugal;France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 38 | EUCTR2009-009366-13-ES (EUCTR) | 18/11/2009 | 24/09/2009 | Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Hipertensión Arterial PulmonarPulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: treprostinil dietanolamina Product Code: UT-15C SR INN or Proposed INN: treprostinil dietanolamina Product Name: treprostinil dietanolamina Product Code: UT-15C INN or Proposed INN: treprostinil dietanolamina Product Name: treprostinil dietanolamina Product Code: UT-15C INN or Proposed INN: treprostinil dietanolamina | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 39 | EUCTR2009-009366-13-IT (EUCTR) | 17/11/2009 | 11/12/2009 | A 16-Week, International, Multicenter, Double-Blind, Randomized,Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C SustainedRelease Tablets in Subjects with Pulmonary ArterialHypertension - Freedom C | A 16-Week, International, Multicenter, Double-Blind, Randomized,Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C SustainedRelease Tablets in Subjects with Pulmonary ArterialHypertension - Freedom C | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911 | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil | UNITED THERAPEUTICS | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 40 | EUCTR2009-009366-13-NL (EUCTR) | 04/11/2009 | 18/08/2009 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 41 | EUCTR2009-009366-13-BE (EUCTR) | 23/10/2009 | 04/09/2009 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Portugal;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 42 | EUCTR2009-009366-13-AT (EUCTR) | 22/10/2009 | 23/09/2009 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 43 | EUCTR2009-009366-13-GB (EUCTR) | 02/09/2009 | 07/08/2009 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 44 | NCT00963001 (ClinicalTrials.gov) | September 2009 | 19/8/2009 | Effect of Food on the Pharmacokinetics of Oral Treprostinil | Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers | Hypertension, Pulmonary;Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine;Other: Standardized meals | United Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 32 | Phase 1 | United States |
| 45 | NCT00963027 (ClinicalTrials.gov) | September 2009 | 19/8/2009 | Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil | An Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult Volunteers | Hypertension, Pulmonary;Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine;Drug: Esomeprazole | United Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 30 | Phase 1 | United States |
| 46 | EUCTR2006-000804-18-DE (EUCTR) | 10/04/2008 | 12/12/2007 | An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Germany;Netherlands;Sweden | ||
| 47 | EUCTR2006-000800-17-DE (EUCTR) | 02/04/2008 | 19/05/2008 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 48 | EUCTR2006-000800-17-IT (EUCTR) | 27/08/2007 | 10/05/2007 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine | UNITED THERAPEUTICS | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 49 | EUCTR2006-000801-50-NL (EUCTR) | 03/07/2007 | 02/04/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Belgium;Austria;Netherlands;Italy | ||
| 50 | EUCTR2006-000804-18-NL (EUCTR) | 19/06/2007 | 01/12/2006 | An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 16.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden | ||
| 51 | EUCTR2006-000800-17-NL (EUCTR) | 19/06/2007 | 01/12/2006 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 52 | EUCTR2006-000801-50-IT (EUCTR) | 12/06/2007 | 21/06/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Pulmonary Arterial Hypertension (PAH) MedDRA version: 6.1;Level: PT;Classification code 10037400 | Product Name: treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | UNITED THERAPEUTICS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Netherlands;Belgium;France;Italy;Austria | |||
| 53 | EUCTR2006-000804-18-FR (EUCTR) | 11/06/2007 | 19/01/2007 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 54 | EUCTR2006-000804-18-ES (EUCTR) | 29/05/2007 | 02/03/2010 | Estudio abierto de ampliación con UT-15C LP en sujetos con hipertensión arterial pulmonarAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Estudio abierto de ampliación con UT-15C LP en sujetos con hipertensión arterial pulmonarAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Cortocircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) VIH. MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Portugal;France;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 55 | EUCTR2006-000800-17-ES (EUCTR) | 29/05/2007 | 02/03/2010 | Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Corticircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 56 | EUCTR2006-000801-50-FR (EUCTR) | 21/05/2007 | 19/01/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Belgium;Austria;Netherlands;Italy | ||
| 57 | EUCTR2006-000800-17-FR (EUCTR) | 21/05/2007 | 19/01/2007 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 58 | EUCTR2006-000804-18-GB (EUCTR) | 04/05/2007 | 22/11/2006 | An extension study of UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden | ||
| 59 | EUCTR2006-000804-18-BE (EUCTR) | 23/04/2007 | 25/01/2007 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 60 | EUCTR2006-000804-18-AT (EUCTR) | 19/02/2007 | 17/01/2007 | An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungs | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden | ||
| 61 | EUCTR2006-000801-50-AT (EUCTR) | 19/02/2007 | 17/01/2007 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Netherlands;Belgium;France;Italy;Austria | |||
| 62 | EUCTR2006-000800-17-IE (EUCTR) | 15/02/2007 | 13/11/2006 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 63 | EUCTR2006-000804-18-IE (EUCTR) | 15/02/2007 | 09/11/2006 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 64 | EUCTR2006-000800-17-AT (EUCTR) | 19/01/2007 | 17/01/2007 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 65 | EUCTR2006-000800-17-GB (EUCTR) | 18/01/2007 | 22/11/2006 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or 3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprosinil Diethanolamine Product Code: UT-15C-SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprosinil Diethanolamine Product Code: UT-15C-SR INN or Proposed INN: Treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 66 | NCT01027949 (ClinicalTrials.gov) | May 2006 | 4/12/2009 | An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension | An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine | United Therapeutics | NULL | Active, not recruiting | 12 Years | N/A | All | 900 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic |
| 67 | EUCTR2009-009366-13-DE (EUCTR) | 23/09/2009 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05743374 (ClinicalTrials.gov) | February 2023 | 14/2/2023 | Micronutrient and Additive Modifications May Optimize Diet To Health | Micronutrient and Additive Modifications May Optimize Diet To Health | Ulcerative Colitis;Diet Habit;Microbial Colonization | Other: Normal diet;Dietary Supplement: E400 elimination | Region Skane | NULL | Not yet recruiting | 18 Years | N/A | All | 70 | N/A | Sweden |
| 2 | NCT05507931 (ClinicalTrials.gov) | February 2023 | 17/8/2022 | Broccoli Sprouts for Mild Ulcerative Colitis | A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis | Ulcerative Colitis;Ulcerative Colitis Chronic Mild | Dietary Supplement: 1 Serving of broccoli sprouts;Dietary Supplement: 3 Servings of broccoli sprouts | University of Michigan | University of Maine | Not yet recruiting | 18 Years | N/A | All | 40 | N/A | United States |
| 3 | NCT05561738 (ClinicalTrials.gov) | January 1, 2023 | 13/9/2022 | Nicotinamide Riboside in Ulcerative Colitis | Nicotinamide Riboside in Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Nicotinamide Riboside Chloride;Dietary Supplement: Placebo;Other: Standard of Care | University of Pittsburgh | Crohn's and Colitis Foundation | Not yet recruiting | N/A | 18 Years | All | 40 | N/A | United States |
| 4 | NCT05579483 (ClinicalTrials.gov) | December 2022 | 4/10/2022 | Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures | Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures | Ulcerative Colitis | Dietary Supplement: Prebiotics;Dietary Supplement: Placebo | Wageningen University | Winclove Probiotics B.V.;China Scholarship Council | Not yet recruiting | 18 Years | 65 Years | All | 60 | N/A | Netherlands |
| 5 | NCT05539625 (ClinicalTrials.gov) | September 2022 | 4/8/2022 | Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis | Mitochondrial Antioxidant Therapy to Resolve Inflammation in Ulcerative Colitis (Mini-MARVEL): A Phase 2b Feasibility Randomised Placebo Controlled Trial of Oral MitoQ in Mild-tomoderately Active Paediatric UC | Ulcerative Colitis | Dietary Supplement: MitoQ;Other: Placebo | University of Edinburgh | The Jon Moulton Charity Trust;MitoQ | Not yet recruiting | 6 Years | 17 Years | All | 120 | Phase 2 | NULL |
| 6 | NCT05652621 (ClinicalTrials.gov) | July 31, 2022 | 9/9/2022 | Efficacy of Probiotics in Patients With IBD | Clinical Efficacy and Mechanism of Probiotics in the Adjuvant Treatment of Ulcerative Colitis and Irritable Bowel Syndrome | Ulcerative Colitis;Irritable Bowel Syndrome | Dietary Supplement: probiotics | The First Affiliated Hospital of Xinxiang Medical College | NULL | Recruiting | 18 Years | 80 Years | All | 200 | N/A | China |
| 7 | NCT05761327 (ClinicalTrials.gov) | June 3, 2022 | 11/2/2023 | Investigation of the Effects of Curcumin and Resveratrol Supplements Added to the Mediterranean Diet on Disease Severity and Inflammatory Biomarkers in Patients With Ulcerative Colitis | Investigation of the Effects of Curcumin and Resveratrol Supplements Added to the Mediterranean Diet on Disease Severity and Inflammatory Biomarkers in Patients With Ulcerative Colitis | Ulcerative Colitis | Other: Mediterranean Diet;Dietary Supplement: Curcumin Supplementation;Dietary Supplement: Resveratrol Supplementation | Ardahan University | NULL | Recruiting | 18 Years | 70 Years | All | 45 | N/A | Turkey |
| 8 | NCT04276740 (ClinicalTrials.gov) | May 31, 2022 | 12/2/2020 | MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis | Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC | Ulcerative Colitis Flare | Dietary Supplement: MitoQ;Other: Placebo | University of Edinburgh | JP Moulton Charitable Foundation;MitoQ | Not yet recruiting | 18 Years | N/A | All | 206 | Phase 2 | NULL |
| 9 | NCT04749576 (ClinicalTrials.gov) | December 15, 2020 | 9/12/2020 | Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease | Efficacy of Nutritional Saffron Supplement As An Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease | Ulcerative Colitis | Dietary Supplement: saffron supplement for IBD | Howard University | NULL | Recruiting | 18 Years | 80 Years | All | 100 | N/A | United States |
| 10 | NCT04505410 (ClinicalTrials.gov) | November 18, 2020 | 5/8/2020 | Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis | A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Second Line Induction With Biological Medications Tofacitinib, Ustekinumab or Vedolizumab | Ulcerative Colitis | Drug: Tofacitinib;Other: Fast Mimicking Diet;Drug: Ustekinumab induction;Drug: Infliximab induction | University of Miami | Pfizer | Recruiting | 18 Years | N/A | All | 76 | Phase 3 | United States |
| 11 | EUCTR2018-005086-39-BG (EUCTR) | 27/10/2020 | 25/06/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 12 | JPRN-UMIN000041972 | 2020/10/01 | 01/10/2020 | Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. | Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. - BS-UC-2020 | ulcerative colitis | Broccoli Sprouts (20 g/day, 8 weeks) Alfalfa Sprouts (20 g/day, 8 weeks) | University of Tsukuba | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 13 | NCT04225819 (ClinicalTrials.gov) | October 1, 2020 | 3/1/2020 | Adjunctive Treatment With Vitamin D3 in Patients With Active IBD | Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial | IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency | Dietary Supplement: Vitamin D3;Other: Placebo | Massachusetts General Hospital | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | United States |
| 14 | NCT04188990 (ClinicalTrials.gov) | June 15, 2020 | 2/12/2019 | Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition | Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition | Pancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal Cancer | Dietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current care | Hospital Galdakao-Usansolo | NULL | Active, not recruiting | 18 Years | N/A | All | 900 | N/A | Spain |
| 15 | NCT03980405 (ClinicalTrials.gov) | April 1, 2020 | 5/6/2019 | Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis | Combination Therapy With Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative Colitis: A Single Blinded, International Randomized Controlled Trial | Ulcerative Colitis | Dietary Supplement: Group 1- Control Diet;Dietary Supplement: Group 2- UCD Diet | Prof. Arie Levine | NULL | Terminated | 10 Years | 19 Years | All | 12 | N/A | Israel |
| 16 | NCT04332328 (ClinicalTrials.gov) | April 1, 2020 | 31/3/2020 | Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt | Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt | Diet in Ulcerative Colitis Patients | Dietary Supplement: Diet | Assiut University | NULL | Not yet recruiting | N/A | N/A | All | 50 | NULL | |
| 17 | NCT02277223 (ClinicalTrials.gov) | March 1, 2020 | 25/10/2014 | Curcumin in Pediatric Ulcerative Colitis | Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Curcumin;Drug: Placebo | Schneider Children's Medical Center, Israel | NULL | Withdrawn | 6 Years | 18 Years | All | 0 | Phase 3 | Israel |
| 18 | EUCTR2019-003220-21-GB (EUCTR) | 26/02/2020 | 12/12/2019 | Management of diarrhoea in ulcerative colitis: multi-arm multi stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. | Management of diarrhoea in ulcerative colitis: multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. - MODULATE | Diarrhoea in patients with stable ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10066557;Term: Chronic diarrhoea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amitriptyline Product Name: Amitriptyline INN or Proposed INN: Amitriptyline hydrochloride Product Name: Ondansetron INN or Proposed INN: Ondansetron hydrochloride dihydrate Product Name: Loperamide INN or Proposed INN: loperamide hydrochloride | University of Leeds | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 491 | Phase 2;Phase 3 | United Kingdom | ||
| 19 | NCT04241029 (ClinicalTrials.gov) | February 25, 2020 | 17/1/2020 | Boosting Biologics in UC | Boosting Biologics in Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Dietary Supplement: IDOFORM®Travel | Oslo University Hospital | Helse Sor-Ost | Recruiting | 18 Years | 75 Years | All | 20 | Phase 1 | Norway |
| 20 | NCT03998488 (ClinicalTrials.gov) | January 31, 2020 | 24/6/2019 | Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis | A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: Fecal Microbiota Transplantation;Dietary Supplement: Psyllium Husk Powder | Weill Medical College of Cornell University | Crohn's and Colitis Foundation | Recruiting | 18 Years | 89 Years | All | 135 | Phase 2 | United States |
| 21 | EUCTR2018-005086-39-HR (EUCTR) | 16/12/2019 | 17/01/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 22 | NCT05656391 (ClinicalTrials.gov) | December 16, 2019 | 1/12/2022 | Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis | Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis: A Pilot Study | Ulcerative Colitis in Remission | Dietary Supplement: Treatment vs control bread | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | NULL | Completed | 18 Years | N/A | All | 31 | N/A | Spain |
| 23 | EUCTR2018-005086-39-HU (EUCTR) | 28/10/2019 | 08/04/2019 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 24 | EUCTR2018-005086-39-PL (EUCTR) | 07/10/2019 | 06/05/2019 | A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | Russian Federation;Hungary;United States;Moldova, Republic of;Ukraine;Poland;Georgia;Belarus;Serbia;Bulgaria;Bosnia and Herzegovina;Croatia | ||
| 25 | NCT04006977 (ClinicalTrials.gov) | October 2019 | 1/7/2019 | Multistrain Probiotics Reduces UC Depression and Anxiety Scores | Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: a multistrain probiotic product (DSF);Dietary Supplement: Placebo | Xijing Hospital of Digestive Diseases | MENDES SA | Not yet recruiting | 18 Years | 65 Years | All | 60 | N/A | China |
| 26 | NCT04102852 (ClinicalTrials.gov) | September 30, 2019 | 17/9/2019 | Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients | The Role of Lactobacillus Rhamnosus GG (ATCC 53103) in the Modulation of the Inflammatory Process in the Mucosa of Ulcerative Colitis (UC) Patients With Mild-moderate Clinical Activity | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Dietary Supplement: Lactobacillus rhamnosus GG ATCC 53103 | San Giovanni Addolorata Hospital | Onlus S. Andrea | Completed | 18 Years | 65 Years | All | 76 | Phase 1/Phase 2 | Italy |
| 27 | NCT03847467 (ClinicalTrials.gov) | September 20, 2019 | 12/2/2019 | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Drug: 2'-Fucosyllactose;Other: Placebo | Children's Hospital Medical Center, Cincinnati | Broad Institute;University of Cincinnati;Connecticut Children's Medical Center | Recruiting | 11 Years | 25 Years | All | 216 | Phase 1/Phase 2 | United States |
| 28 | NCT03941418 (ClinicalTrials.gov) | June 1, 2019 | 5/5/2019 | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Ulcerative Colitis;Crohn Disease | Dietary Supplement: Boulardii;Dietary Supplement: Placebo | University Clinic Dr Dragisa Misovic-Dedinje | University Clinic Zvezdara | Not yet recruiting | 18 Years | 80 Years | All | 150 | N/A | NULL |
| 29 | NCT03720002 (ClinicalTrials.gov) | May 29, 2019 | 21/10/2018 | HF2 Therapy in the Treatment of Active Ulcerative Colitis | HF2 Therapy in the Treatment of Active Ulcerative Colitis: | Ulcerative Colitis | Dietary Supplement: HF2 | Sheba Medical Center | NULL | Recruiting | 18 Years | 70 Years | All | 52 | Phase 1/Phase 2 | Greece;Israel |
| 30 | NCT02201758 (ClinicalTrials.gov) | December 2018 | 18/7/2014 | Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment | Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment. | Ulcerative Colitis | Dietary Supplement: Flaxseed lignan-enriched complex (FLC);Other: Placebo | University of Saskatchewan | Royal University Hospital Foundation | Unknown status | 18 Years | N/A | All | 56 | Phase 2 | Canada |
| 31 | NCT02469220 (ClinicalTrials.gov) | July 1, 2018 | 8/6/2015 | Diet Treatment of Patients With Ulcerative Colitis in Remission | Diet Treatment of Patients With Ulcerative Colitis in Remission | Ulcerative Colitis | Dietary Supplement: Low FODMAP;Dietary Supplement: Standardized FODMAP | Vendsyssel Hospital | NULL | Completed | 18 Years | 70 Years | All | 19 | N/A | Denmark |
| 32 | NCT04329481 (ClinicalTrials.gov) | June 12, 2018 | 29/3/2020 | The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients | The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients | Ulcerative Colitis;Crohn Disease;Inflammatory Bowel Diseases | Dietary Supplement: Mycodigest supplement | Tel-Aviv Sourasky Medical Center | NULL | Recruiting | 18 Years | 70 Years | All | 100 | N/A | Israel |
| 33 | NCT03594708 (ClinicalTrials.gov) | April 30, 2018 | 19/1/2018 | Immunonutrition in Ulcerative Colitis | Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Nutrition supplement;Dietary Supplement: Placebo supplement | Baptist Memorial Health Care Corporation | NULL | Unknown status | 18 Years | N/A | All | 30 | N/A | United States |
| 34 | NCT03444311 (ClinicalTrials.gov) | March 8, 2018 | 8/2/2018 | Combined Nutritional Therapies for the Treatment of Ulcerative Colitis | Development of Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Through the Increase of the Biodiversity of the Microbiota. | Colitis, Ulcerative | Dietary Supplement: A: 1 dosis;Dietary Supplement: B: 2 dosis | AB Biotics, SA | NULL | Terminated | 18 Years | 65 Years | All | 12 | N/A | Spain |
| 35 | NCT03309865 (ClinicalTrials.gov) | December 25, 2017 | 7/10/2017 | Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis. | A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis. | Ulcerative Colitis;Dietary Modification | Dietary Supplement: semi-vegetarian diet;Drug: Vedolizumab Injection | Mayo Clinic | NULL | Withdrawn | 18 Years | N/A | All | 0 | Early Phase 1 | United States |
| 36 | NCT03266484 (ClinicalTrials.gov) | November 13, 2017 | 25/8/2017 | Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease | Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Dietary Supplement: Probiotic Mixture;Dietary Supplement: Placebo | Massachusetts General Hospital | Winclove Bio Industries BV | Active, not recruiting | 18 Years | 75 Years | All | 100 | N/A | United States |
| 37 | NCT03122613 (ClinicalTrials.gov) | June 19, 2017 | 7/4/2017 | Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis | A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis | Ulcerative Colitis in Remission | Dietary Supplement: Curcumin;Drug: Placebo | Chinese University of Hong Kong | NULL | Terminated | 18 Years | N/A | All | 29 | N/A | Hong Kong |
| 38 | NCT03415711 (ClinicalTrials.gov) | April 28, 2017 | 5/1/2018 | PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis | A Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UC | Ulcerative Colitis | Dietary Supplement: VSL#3®;Drug: Mesalamine;Drug: Placebo | VSL Pharmaceuticals | Actial Farmaceutica S.r.l. | Terminated | 18 Years | 85 Years | All | 14 | N/A | Italy |
| 39 | NCT03798210 (ClinicalTrials.gov) | January 1, 2017 | 7/1/2019 | Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis | The Effect of Lactobacillus Reuteri ATCC PTA 4659 in Patients With Ulcerative Colitis | Ulcerative Colitis Flare | Dietary Supplement: Lactobacillus reuteri;Dietary Supplement: Placebo | Uppsala University | NULL | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | Sweden |
| 40 | NCT03136419 (ClinicalTrials.gov) | October 31, 2016 | 5/4/2017 | Microbiota and Immune microEnvironment in Pouchitis | Microbiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch Mucosa | Pouchitis;Ulcerative Colitis;Ileal Pouch | Dietary Supplement: Lactobacillus casei DG;Dietary Supplement: Placebo | University of Padova | NULL | Recruiting | 18 Years | 100 Years | All | 32 | N/A | Italy |
| 41 | NCT02825914 (ClinicalTrials.gov) | September 1, 2016 | 30/6/2016 | CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) | CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) | Colitis, Ulcerative;Inflammatory Bowel Diseases | Dietary Supplement: Casein glycomacropeptide (CGMP);Dietary Supplement: Placebo | University of Aarhus | NULL | Completed | 18 Years | N/A | All | 80 | N/A | Denmark |
| 42 | NCT02865707 (ClinicalTrials.gov) | August 2016 | 12/7/2016 | Ulcerative Colitis Relapse Prevention by Prebiotics | Prevention of Ulcerative Colitis by Prebiotics: Efficacy and Protective Mechanisms | Ulcerative Colitis | Dietary Supplement: Synergy-1;Dietary Supplement: Maltodextrin | University of Alberta | University of British Columbia | Completed | 18 Years | 75 Years | All | 89 | N/A | Canada |
| 43 | NCT02683759 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis | The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicyclic acid | Asian Institute of Gastroenterology, India | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India |
| 44 | NCT02683733 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis | The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicylic acid | Asian Institute of Gastroenterology, India | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India |
| 45 | NCT02345733 (ClinicalTrials.gov) | September 1, 2015 | 19/1/2015 | Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis | Use of a Novel Diet (UC DIET) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study | Ulcerative Colitis (UC) | Other: Ulcerative Colitis Diet;Drug: Antibiotic cocktail | Prof. Arie Levine | NULL | Completed | 8 Years | 19 Years | All | 20 | Phase 4 | United States;Canada;Israel |
| 46 | NCT02084550 (ClinicalTrials.gov) | September 2015 | 5/3/2014 | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial | Ulcerative Colitis | Dietary Supplement: Vaminolac;Other: Saline | Aarhus University Hospital | NULL | Active, not recruiting | 18 Years | 50 Years | All | 8 | N/A | Denmark |
| 47 | NCT02361957 (ClinicalTrials.gov) | November 2014 | 15/1/2015 | The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients | The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Ecologic 825;Dietary Supplement: Placebo | Wageningen University | NULL | Suspended | 18 Years | 65 Years | Both | 40 | N/A | Netherlands |
| 48 | NCT02217722 (ClinicalTrials.gov) | October 2014 | 20/7/2014 | Use of the Ulcerative Colitis Diet for Induction of Remission | An Open Label Non Randomized Pilot Study: Use of the Ulcerative Colitis Diet for Induction of Remission. | Ulcerative Colitis (UC) | Other: Ulcerative Colitis Diet;Drug: Antibiotic cocktail | Prof. Arie Levine | NULL | Terminated | 5 Years | 18 Years | Both | 9 | N/A | Israel |
| 49 | NCT02179372 (ClinicalTrials.gov) | June 2014 | 29/6/2014 | Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases | Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases | Ulcerative Colitis;Crohn's Disease | Dietary Supplement: Eicosapentaenoic acid;Dietary Supplement: Medium chain fatty acid (placebo) | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | NULL | Completed | 18 Years | 80 Years | Both | 60 | N/A | Italy |
| 50 | NCT02069561 (ClinicalTrials.gov) | January 2014 | 19/2/2014 | Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer | Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease | Ulcerative Colitis | Dietary Supplement: Eicosapentaenoic Acid | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | NULL | Completed | 18 Years | 70 Years | Both | 25 | N/A | Italy |
| 51 | NCT01771224 (ClinicalTrials.gov) | January 2013 | 16/1/2013 | Effect of FAn-7 in UC Activity | Effect of Palmitoleic Acid (FAn-7) on Expression of HNF4? and Ulcerative Colitis (UC) Activity | Inflammatory Bowel Disease;Ulcerative Colitis | Dietary Supplement: Palmitoleic acid | National Institute of Medical Sciences and Nutrition, Salvador Zubiran | NULL | Recruiting | 18 Years | 59 Years | Both | 20 | Phase 0 | Mexico |
| 52 | NCT01078935 (ClinicalTrials.gov) | December 2012 | 1/3/2010 | The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation | The Effect of Probiotics on Bowel Disease | Crohn's Disease;Ulcerative Colitis | Dietary Supplement: probiotics;Dietary Supplement: placebo | The Baruch Padeh Medical Center, Poriya | Ministry of Health, Israel | Not yet recruiting | 18 Years | 80 Years | Both | 100 | Phase 4 | NULL |
| 53 | NCT01783119 (ClinicalTrials.gov) | August 2012 | 31/1/2013 | Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis | Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Aloe Barbadensis Miller;Dietary Supplement: placebo water | National Institute of Medical Sciences and Nutrition, Salvador Zubiran | NULL | Recruiting | 18 Years | 59 Years | Both | 60 | Phase 0 | Mexico |
| 54 | NCT01877577 (ClinicalTrials.gov) | April 2012 | 11/6/2013 | Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D | Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial. | Crohn's Disease (CD);Ulcerative Colitis (UC) | Dietary Supplement: Vitamin D3 | University of California, San Francisco | NULL | Completed | 18 Years | N/A | Both | 30 | N/A | United States |
| 55 | NCT01496053 (ClinicalTrials.gov) | December 2011 | 15/12/2011 | Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD) | Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study | Ulcerative Colitis;Crohn's Disease;Inflammatory Bowel Disease | Dietary Supplement: AndoSan;Dietary Supplement: Sugar Extract | Oslo University Hospital | ImmunoPharma AS | Completed | 18 Years | 60 Years | All | 100 | Phase 2/Phase 3 | Norway |
| 56 | NCT01320436 (ClinicalTrials.gov) | July 2011 | 21/3/2011 | Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis | Randomized, Double-blind, Placebo-controlled Study to Evaluated the Efficacy of Combining Curcumin+5ASA Medication Versus 5ASA Medication Alone on Active Mild to Moderate Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Curcumin;Drug: 5-aminosalicylic acid | Sheba Medical Center | NULL | Completed | 18 Years | 70 Years | Both | 50 | Phase 3 | Israel |
| 57 | NCT01772615 (ClinicalTrials.gov) | May 2011 | 17/1/2013 | Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle | Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle | Ulcerative Colitis | Drug: Ciprofloxacin;Dietary Supplement: E. coli Nissle | Hvidovre University Hospital | NULL | Completed | 18 Years | N/A | Both | 100 | Phase 4 | Denmark |
| 58 | NCT01065571 (ClinicalTrials.gov) | January 2010 | 4/2/2010 | Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity | Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity | Ulcerative Colitis | Dietary Supplement: carrageenan;Other: dietary intervention with no-carrageenan diet | University of Illinois at Chicago | The Broad Foundation;University of Chicago | Completed | 18 Years | N/A | All | 15 | N/A | United States |
| 59 | NCT00793130 (ClinicalTrials.gov) | November 2008 | 16/11/2008 | The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label | The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label | Ulcerative Colitis | Dietary Supplement: Coltect | Tel-Aviv Sourasky Medical Center | NULL | Recruiting | 18 Years | 75 Years | Both | 30 | N/A | Israel |
| 60 | NCT00751933 (ClinicalTrials.gov) | October 2008 | 11/9/2008 | Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis | A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis. | Ulcerative Colitis | Biological: Vaccine Vivotif + Vaccine Dukoral + oats;Biological: Vaccine Vivotif + Vaccine Dukoral;Dietary Supplement: Oats;Other: Placebo | Haukeland University Hospital | Helse Vest | Terminated | 18 Years | 80 Years | All | 3 | Phase 2 | Norway |
| 61 | ChiCTR-TRC-08000145 | 2008-09-01 | 2008-08-25 | The study of the treatment and rehabilitation of ulcerative colitis | The study of the treatment and rehabilitation of ulcerative colitis | Ulcerative Colitis | 1:5-ASA and low residue diet;2:5-ASA and EN;3:5-ASA and low residue diet and microecology prepar;4:5-ASA and low residue diet ang Gln;5:5-ASA and EN and Gln and microecology preparation; | Friendship Hospital of Capital Medical University | NULL | Completed | 18 | 70 | Both | 1:60;2:60;3:60;4:60;5:60; | I (Phase 1 study) | China |
| 62 | NCT00621257 (ClinicalTrials.gov) | January 2008 | 11/2/2008 | Vitamin D Levels in Children With IBD | Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD. | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Dietary Supplement: ergocalciferol;Dietary Supplement: Cholecalciferol | Boston Children’s Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Crohn's and Colitis Foundation;NASPGHAN Foundation | Terminated | 5 Years | 21 Years | All | 134 | N/A | United States |
| 63 | NCT00578799 (ClinicalTrials.gov) | December 2007 | 18/12/2007 | Effects of Probiotics in Patients With Ulcerative Colitis | Effects of Probiotics in Patients With Ulcerative Colitis. | Ulcerative Colitis | Dietary Supplement: Kyo-Dophilus;Dietary Supplement: placebo | University of California, Irvine | Wakunaga Pharmaceutical Co., Ltd. | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 1 | United States |
| 64 | NCT02093767 (ClinicalTrials.gov) | August 2007 | 19/3/2014 | Oligofructose-enriched Inulin for the Treatment of Mild to Moderate Active Ulcerative Colitis | Open-Label Trial of a Prebiotic Preparation Containing Inulin and Oligofructose (Synergy-1) for the Treatment of Mild to Moderate Acute Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Synergy1 | University of Alberta | Canadian Institutes of Health Research (CIHR);Crohn's and Colitis Canada;Beneo GmbH | Completed | 18 Years | 65 Years | All | 24 | N/A | Canada |
| 65 | NCT00403923 (ClinicalTrials.gov) | April 2007 | 24/11/2006 | Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis | A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis | Lactose Intolerance;Ulcerative Colitis | Dietary Supplement: Lactose in water | University Hospitals, Leicester | NULL | Completed | 18 Years | N/A | Both | 48 | United Kingdom | |
| 66 | NCT00951548 (ClinicalTrials.gov) | October 2006 | 2/8/2009 | Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis | Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study | Ulcerative Colitis | Dietary Supplement: VSL#3;Dietary Supplement: Placebo | VSL Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 144 | N/A | Italy |
| 67 | EUCTR2004-000611-25-IE (EUCTR) | 19/10/2004 | 16/08/2004 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | Maintenance of remission of ulcerative colitis | Product Name: OPC-6535 Product Code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 68 | EUCTR2004-000611-25-HU (EUCTR) | 15/10/2004 | 21/07/2004 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | Maintenance of remission of ulcerative colitis | Product Name: OPC-6535 Product Code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 69 | NCT00259558 (ClinicalTrials.gov) | April 2003 | 25/11/2005 | Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis | Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa | Ulcerative Colitis | Drug: retarded release phosphatidylcholine | Heidelberg University | Prof. Wolfgang Stremmel;Dietmar Hopp Stiftung | Completed | 16 Years | 90 Years | Both | 60 | Phase 2 | Germany |
| 70 | NCT00259571 (ClinicalTrials.gov) | April 2003 | 28/11/2005 | Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis. | Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte (Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa. | Ulcerative Colitis | Drug: retarded release phosphatidylcholine | Heidelberg University | Dietmar Hopp Stiftung | Withdrawn | 15 Years | 80 Years | Both | 0 | Phase 2/Phase 3 | Germany |
| 71 | NCT00259545 (ClinicalTrials.gov) | February 2003 | 25/11/2005 | Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis | Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden | Ulcerative Colitis;Phosphatidylcholine | Drug: Retarded Release Phosphatidylcholine (rPC) | Heidelberg University | Professor Wolfgang Stremmel;Dietmar Hopp Stiftung | Completed | 16 Years | 90 Years | Both | 60 | Phase 2 | Germany |
| 72 | NCT00940576 (ClinicalTrials.gov) | July 2000 | 15/7/2009 | Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases | Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study. | Ulcerative Colitis;Crohns Disease | Dietary Supplement: mare´s milk;Other: placebo drink | University of Jena | German Federal Ministry of Education and Research | Completed | 10 Years | 50 Years | All | 17 | N/A | Germany |
240. フェニルケトン尿症
臨床試験数 : 143 / 薬物数 : 90 - (DrugBank : 10) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 5
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04272736 (ClinicalTrials.gov) | December 1, 2022 | 29/8/2018 | PKU Low Calorie Drink Study | Evaluating the Compliance, Acceptability, Safety and Tolerance of a Lower Calorie Protein Substitute for the Dietary Management of Phenylketonuria in Children and Adults - a Pilot Study | Phenylketonurias;Hyperphenylalaninaemia | Dietary Supplement: Low calorie protein substitute | Nutricia UK Ltd | NULL | Not yet recruiting | 3 Years | N/A | All | 30 | N/A | NULL |
| 2 | NCT05270837 (ClinicalTrials.gov) | June 17, 2022 | 1/2/2022 | Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria | A Phase 3 Multi-Center Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase in Adolescent Subjects (Ages 12-17) With Phenylketonuria Featuring an Open-Label Randomized Two-Arm (Active vs Diet-Only Control) Design | Phenylketonuria (PKU) | Drug: Pegvaliase;Other: Diet Only | BioMarin Pharmaceutical | NULL | Recruiting | 12 Years | 17 Years | All | 54 | Phase 3 | United States;Germany |
| 3 | NCT04898829 (ClinicalTrials.gov) | May 18, 2022 | 11/5/2021 | Evaluation of PKU Explore France | An Exploratory Study to Evaluate the Acceptability of PKU Explore, a Food for Special Medical Purposes, for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 3 Years of Age With Regard to Product-acceptability, Tolerance, Phe Levels and Growth | Phenylketonurias | Dietary Supplement: PKU explore | Vitaflo International, Ltd | NULL | Recruiting | 6 Months | 3 Years | All | 10 | N/A | France |
| 4 | NCT05096988 (ClinicalTrials.gov) | November 23, 2021 | 14/10/2021 | Evaluation of PKU Sphere Liquid | A Study to Evaluate the Acceptability, Tolerance and Adherence of Children and Adults Consuming PKU Sphere Liquid, a Food for Special Medical Purposes (FSMP), for the Dietary Management of Phenylketonuria (PKU) | Phenylketonurias | Dietary Supplement: PKU sphere liquid | Vitaflo International, Ltd | NULL | Active, not recruiting | 3 Years | N/A | All | 19 | N/A | United Kingdom |
| 5 | NCT05051657 (ClinicalTrials.gov) | June 14, 2021 | 10/9/2021 | Evaluation of PKU Express Plus | A Study To Evaluate The Acceptability Of PKU Express Plus, A Food For Special Medical Purposes (FSMP), In Children And Adults With Phenylketonuria (PKU) | Phenylketonurias;PKU | Dietary Supplement: PKU express plus | Vitaflo International, Ltd | NULL | Recruiting | 3 Years | N/A | All | 15 | N/A | United Kingdom |
| 6 | NCT04375592 (ClinicalTrials.gov) | February 1, 2021 | 21/4/2020 | Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Management of Phenylketonuria | XPhe Minis - Acceptability and Tolerance Market Research | Phenylketonurias;Hyperphenylalaninaemia;Tetrahydrobiopterin Deficiency | Dietary Supplement: Phenylalanine-free protein substitute in tablet form (XPhe minis) | metaX Institut fuer Diatetik GmbH | Birmingham Children's Hospital | Recruiting | 7 Years | 18 Years | All | 10 | United Kingdom | |
| 7 | NCT05062226 (ClinicalTrials.gov) | September 16, 2020 | 6/9/2021 | GMP Case Studies of Tolerance, Safety and Acceptability in PKU and TYR | Evaluating the Tolerance, Safety and Acceptability of GMP-based Protein Substitutes for the Dietary Management of Phenylketonuria and Tyrosinaemia in Children and Adults: a Case Study Series | PKU;Tyrosinemias | Dietary Supplement: PKU/TYR GMP Protein Substitute | Nutricia UK Ltd | NULL | Recruiting | 3 Years | N/A | All | 45 | N/A | United Kingdom |
| 8 | NCT04302194 (ClinicalTrials.gov) | May 1, 2020 | 7/3/2020 | Early Dietary Treated Patients With Phenylketonuria Can Achieve Normal Growth and Mental Development. | Early Dietary Treated Patients With Phenylketonuria Can Achieve Normal Growth and Mental Development. | Phenylketonurias | Dietary Supplement: phenylalanine restricted diet | Assiut University | NULL | Not yet recruiting | 1 Month | 3 Years | All | 50 | NULL | |
| 9 | NCT04679467 (ClinicalTrials.gov) | January 15, 2020 | 26/11/2020 | Evaluation of PKU Sphere in Italy | An Acceptability Study to Evaluate the Tolerance, Adherence and Metabolic Control of Patients With Phenylketonuria (PKU) Consuming PKU Sphere™, a Glycomacropeptide (GMP) Based Protein Substitute, When Introduced According to a Practical Guide to PKU Sphere. | Phenylketonurias;PKU | Dietary Supplement: PKU sphere | Vitaflo International, Ltd | NULL | Completed | 3 Years | N/A | All | 13 | N/A | Italy |
| 10 | NCT04404530 (ClinicalTrials.gov) | October 8, 2019 | 21/5/2020 | Nutritional Impacts of Palynziq on Patients With Phenylketonuria (PKU) | Palynziq and PKU: Treatment Impacts on Diet Quality, Neurological Health, Nutritional Status, and the Metabolome | Phenylketonurias | Drug: Palynziq | Emory University | BioMarin Pharmaceutical | Recruiting | 16 Years | N/A | All | 45 | United States | |
| 11 | NCT03924180 (ClinicalTrials.gov) | September 19, 2019 | 22/4/2019 | Glytactin EfficiEncy in Non or Insufficiently Treated Adult PHENylketonuria Patients | Glytactin EfficiEncy in Non or Insufficiently Treated Adult PHENylketonuria Patients | Adult Phenylketonuria Non Treated Patients | Dietary Supplement: Dietary Supplement for PKU patients | University Hospital, Tours | NULL | Completed | 18 Years | N/A | All | 13 | N/A | France |
| 12 | NCT03788343 (ClinicalTrials.gov) | August 19, 2019 | 17/12/2018 | Phenylalanine and Its Impact on Cognition | PICO: Phenylalanine and Its Impact on Cognition - Impact of Phenylalanine on Cognitive, Cerebral and Neurometabolic Parameters in Adult Patients With Phenylketonuria | Phenylketonuria | Dietary Supplement: Phenylalanine;Drug: Placebo | University Hospital Inselspital, Berne | University of Zurich | Completed | 18 Years | N/A | All | 90 | Phase 4 | Switzerland |
| 13 | NCT04224142 (ClinicalTrials.gov) | July 29, 2019 | 7/10/2019 | Evaluation of PKU Sphere in Maternal PKU | An Observational Study to Evaluate Metabolic Control and Dietary Management in Women With PKU Taking PKU Sphere During Pre-conception and/or Pregnancy | Maternal Phenylketonuria | Dietary Supplement: PKU sphere | Vitaflo International, Ltd | University College London Hospitals | Recruiting | 16 Years | N/A | Female | 10 | United Kingdom | |
| 14 | NCT03939052 (ClinicalTrials.gov) | July 19, 2019 | 1/5/2019 | Protein Requirements in Adults With Phenylketonuria (PKU) | Protein Requirements in Phenylketonuria (PKU) Patients Compared Using PKU Sphere™ | Glycomacropeptide (GMP) and an L-amino Acid-based Product | Phenylketonuria | Dietary Supplement: Free amino acids intake | University of British Columbia | Vitaflo International, Ltd | Recruiting | 19 Years | 50 Years | All | 6 | N/A | Canada |
| 15 | NCT03333720 (ClinicalTrials.gov) | July 15, 2019 | 18/9/2017 | Compliance, Tolerance and Acceptability of a Tablet Protein Substitute for the Dietary Management of Phenylketonuria | Compliance, Tolerance and Acceptability of a Tablet Protein Substitute for the Dietary Management of Phenylketonuria | Phenylketonurias | Dietary Supplement: Phenylalanine-free protein substitute tablets | Nutricia UK Ltd | NULL | Withdrawn | 8 Years | 100 Years | All | 0 | N/A | NULL |
| 16 | NCT03820804 (ClinicalTrials.gov) | January 7, 2019 | 19/10/2018 | Nutritional Status in Phenylketonuria | Trends in Nutritional Status of Patients With Phenylketonuria | Phenylketonurias | Other: Diet;Drug: Sapropterin | Universidade do Porto | Centro Hospitalar do Porto;BioMarin Pharmaceutical | Completed | 3 Years | N/A | All | 94 | Portugal | |
| 17 | NCT03771391 (ClinicalTrials.gov) | December 6, 2018 | 7/12/2018 | A 16 Week Study Evaluating the Introduction of a GMP Based Protein Substitute in Participants With PKU | Multicentre Study Project to Evaluate the New Generation of Protein Supplements With Glycomacropeptide (GMP) in Patients With Phenylketonuria (PKU) Aged 10 Years and Older Over a 16 Week Period. | Phenylketonurias | Dietary Supplement: PKU Sphere | Vitaflo International, Ltd | Kreiskliniken Reutlingen;Johannes Gutenberg University Mainz | Active, not recruiting | 10 Years | N/A | All | 15 | N/A | Germany |
| 18 | NCT03419819 (ClinicalTrials.gov) | May 1, 2018 | 3/1/2018 | Evaluation of PKU Sphere | Evaluation of the Acceptability, Tolerance, and Satiety of PKU Sphere, a Glycomacropeptide (GMP) Based Medical Food in Patients With Phenylketonuria (PKU). | Phenylketonurias | Dietary Supplement: PKU Sphere | Vitaflo International, Ltd | Oregon Health and Science University | Completed | 3 Years | N/A | All | 28 | N/A | United States |
| 19 | NCT02677870 (ClinicalTrials.gov) | January 22, 2018 | 26/1/2016 | The Effectiveness of Kuvan in Amish PKU Patients | The Effectiveness of High-Dose Synthetic BH4 (Saproterin Dihydrochloride or Kuvan) in Amish PKU Patients | Phenylketonuria | Drug: saproterin dihydrochloride;Other: Diet treatment | University Hospitals Cleveland Medical Center | BioMarin Pharmaceutical | Completed | 2 Years | 60 Years | All | 7 | Phase 4 | United States |
| 20 | NCT03168399 (ClinicalTrials.gov) | June 8, 2017 | 24/5/2017 | Evaluation of PKU Explore | A Study to Evaluate the Acceptability of PKU Explore, a Renovated Phenylalanine Free Second Stage Protein Substitute for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 5 Years of Age With Regard to Product Tolerance and Adherence. | Phenylketonuria;Inborn Errors of Metabolism | Dietary Supplement: PKU Explore | Vitaflo International, Ltd | Birmingham Women's and Children's NHS Foundation Trust | Completed | 6 Months | 5 Years | All | 22 | N/A | United Kingdom |
| 21 | NCT03167697 (ClinicalTrials.gov) | May 1, 2017 | 22/5/2017 | Evaluating the Efficacy of PKU Synergy in Patients Expressing Phenylketonuria or Hyperphenylalaninemia | Evaluating the Efficacy of PKU Synergy in Patients Expressing Phenylketonuria or Hyperphenylalaninemia | Phenylketonurias;Hyperphenylalaninaemia, Type I | Dietary Supplement: Synergy;Other: Routine | Nutricia UK Ltd | NULL | Completed | 16 Years | 100 Years | All | 14 | N/A | United Kingdom |
| 22 | NCT03058848 (ClinicalTrials.gov) | March 6, 2017 | 16/2/2017 | Evaluation of PKU Start | A Study to Evaluate the Acceptability of a New Phenylalanine Free Infant Formula for Use in the Dietary Management of Phenylketonuria in Infants From Birth to 2 Year of Age With Regard to Product Tolerance and Adherence. | Phenylketonuria;Inborn Errors of Metabolism | Dietary Supplement: PKU Start | Vitaflo International, Ltd | NULL | Completed | N/A | 2 Years | All | 10 | N/A | United Kingdom |
| 23 | NCT02915510 (ClinicalTrials.gov) | July 2016 | 8/8/2016 | GMP Drink for PKU Study | Evaluating the Tolerance, Safety and Acceptability of PKU GMPro, a Whey Protein Derived Feed for the Dietary Management of Phenylketonuria in Children and Adults - a Pilot Trial | Phenylketonuria | Dietary Supplement: Glycomacropeptide-based protein substitute | Nutricia UK Ltd | NULL | Completed | 3 Years | N/A | All | 40 | N/A | United Kingdom |
| 24 | NCT02440932 (ClinicalTrials.gov) | November 2014 | 30/4/2015 | Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis | Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis | Phenylketonuria (PKU) | Dietary Supplement: Phenylketonuria-type diet;Other: Normal (control) diet | University of Glasgow | NULL | Completed | 18 Years | 45 Years | Both | 26 | N/A | United Kingdom |
| 25 | EUCTR2010-021343-41-NL (EUCTR) | 21/03/2014 | 30/11/2011 | Variations of blood phenylalanine and tyrosine in children with phenylketonuria under sapropterin | Effect of sapropterin on variations of blood phenylalanine and tyrosine over 24 hours and from day to day in children with phenylketonuria | Phenylketonuria (PKU) is an autosomal recessive metabolic genetic disorder by a mutation in the gene for the enzyme phenylalanine hydroxylase (PAH), rendering it nonfunctional. Left untreated, the disease will result in high concentrations of phenylalanine (Phe) in blood and tissues, likely resulting in severe mental retardation and behavioural problems. Treatment focusus on the restriction of dietary phenylalanine intake with supplementation of a synthetic phenylalaninefree amino acid mixture.;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Kuvan | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 26 | NCT01965691 (ClinicalTrials.gov) | October 2013 | 16/10/2013 | Protein Requirements in Children With Phenylketonuria (PKU) | Application of Stable Isotopes to Determine Protein Requirements in Children With Phenylketonuria (PKU) | Phenylketonuria | Dietary Supplement: Protein intake | University of British Columbia | Rare Disease Foundation, Vancouver, Canada;Saudi Arabian Cultural Bureau, Ottawa | Completed | 5 Years | 18 Years | All | 4 | N/A | Canada |
| 27 | NCT01617070 (ClinicalTrials.gov) | May 2012 | 8/6/2012 | Effects of Kuvan on Melatonin Secretion | Pilot Study to Evaluate Melatonin Secretion as a Marker of Decreased Serotonin in Individuals With PKU: Evaluation of the CNS Effects of Tetrahydrobiopterin | Phenylketonuria (PKU) | Drug: Kuvan;Dietary Supplement: Large Neutral Amino Acid Therapy | University of Southern California | BioMarin Pharmaceutical | Completed | 18 Years | N/A | All | 10 | Phase 4 | United States |
| 28 | NCT01376908 (ClinicalTrials.gov) | June 2011 | 17/6/2011 | Kuvan® in Phenylketonuria Patients Less Than 4 Years Old | A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan®) in Phenylketonuria (PKU) Patients <4 Years Old. | Phenylketonuria | Drug: Kuvan®;Other: Phenylalanine (Phe)-restricted diet | BioMarin Pharmaceutical | NULL | Completed | N/A | 4 Years | All | 56 | Phase 3 | Austria;Belgium;Czechia;Germany;Italy;Netherlands;Slovakia;Turkey;United Kingdom;Czech Republic;Portugal |
| 29 | NCT01412437 (ClinicalTrials.gov) | April 2011 | 1/8/2011 | Neuroimaging and Neurocognitive Assessment and Response to Sapropterin Dihydrochloride Treatment in Phenylketonuria | Multimodal Neuroimaging and Neurocognitive Assessment of Biomarkers and Response to Sapropterin Dihydrochloride Treatment in Phenylketonuria | PKU | Dietary Supplement: diet;Drug: sapropterin dihydrochloride | Children's Research Institute | Georgetown University | Withdrawn | 18 Years | 40 Years | Both | 0 | N/A | United States |
| 30 | NCT00841100 (ClinicalTrials.gov) | December 2008 | 10/2/2009 | Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response | Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response | Phenylketonuria | Drug: Kuvan;Other: Diet | University of Miami | NULL | Completed | 4 Years | N/A | All | 21 | Phase 2 | United States |
| 31 | NCT00892554 (ClinicalTrials.gov) | June 2007 | 1/5/2009 | The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU) | The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria | Phenylketonuria | Dietary Supplement: Docosahexaenoic Acid;Dietary Supplement: Corn/soy oil | Emory University | Atlanta Clinical and Translational Science Institute | Completed | 12 Years | 50 Years | Female | 33 | N/A | United States |
| 32 | EUCTR2005-003777-24-GB (EUCTR) | 17/08/2006 | 20/04/2006 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Phenoptin 20 mg/kg/day to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet - NA | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Phenoptin 20 mg/kg/day to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet - NA | Phenylketonuria (PKU) MedDRA version: 6.1;Classification code 10034872 | Product Name: Phenoptin Product Code: T1401 INN or Proposed INN: Sapropterin Other descriptive name: sapropterin dihydrochloride | BioMarin Pharmaceutical Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Germany;United Kingdom | ||
| 33 | EUCTR2005-003777-24-DE (EUCTR) | 24/03/2006 | 14/12/2005 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Phenoptin 20 mg/kg/day to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet - NA | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Phenoptin 20 mg/kg/day to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet - NA | Phenylketonuria (PKU) MedDRA version: 6.1;Classification code 10034872 | Product Name: Phenoptin Product Code: T1401 INN or Proposed INN: Sapropterin Other descriptive name: sapropterin dihydrochloride | BioMarin Pharmaceutical Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Germany;Spain | ||
| 34 | EUCTR2005-003777-24-ES (EUCTR) | 01/03/2006 | 19/01/2006 | Estudio fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de PhenoptinTM en dosis de 20 mg/kg/dia para aumentar la tolerancia a la fenilalanina en niños fenilcetonúricos que siguen dietas restrictivas en fenilalanina. | Estudio fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de PhenoptinTM en dosis de 20 mg/kg/dia para aumentar la tolerancia a la fenilalanina en niños fenilcetonúricos que siguen dietas restrictivas en fenilalanina. | Fenilcetonuria (Phenylketonuria-PKU) MedDRA version: 6.1;Classification code 10034872 | Product Name: Phenoptin Product Code: T1401 INN or Proposed INN: Sapropterin Other descriptive name: Sapropterin dihydrochloride | BioMarin Pharmaceutical Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Spain;Germany;United Kingdom | ||
| 35 | EUCTR2004-002365-21-DK (EUCTR) | 03/11/2004 | 09/07/2008 | Trial with BH4, a new and simple treatment of phenylketonuria, PKU - BH4 and PKU | Trial with BH4, a new and simple treatment of phenylketonuria, PKU - BH4 and PKU | PKU, phenylketonuria, is a rare, inherited metabolic disease that results in mental retardation if not a very strict low-protein diet is started within the first weeks of life. The conversion of phenylalanine to tyrosine is defect, phe accumulates and leads to brain damage. There are different degrees of severity, reflecting the spectrum of mutant genes. BH4, tetrahydrobiopterin, is co-enzym for the conversion of phe to tyrosine. BH4 can lower phe in some patients with milder forms of PKU. | Product Name: tetrahydrobiopterin | John F. Kennedy Institute | NULL | Not Recruiting | Female: yes Male: yes | Denmark |
299. 嚢胞性線維症
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05523180 (ClinicalTrials.gov) | September 1, 2022 | 22/8/2022 | A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life | A Prospective, Randomized, Double-blinded, Placebo-controlled Study Evaluating the Safety and Impact of resB® Lung Support on Quality of Life in Adult Volunteers With Chronic Obstructive Pulmonary Disease or Non-cystic Fibrosis Bronchiectasis | Chronic Obstructive Pulmonary Disease;Non-cystic Fibrosis Bronchiectasis | Dietary Supplement: Probiotic;Other: Placebo | ResBiotic Nutrition, Inc. | Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | Recruiting | 18 Years | 80 Years | All | 50 | N/A | United States |
| 2 | NCT03931252 (ClinicalTrials.gov) | January 2022 | 25/4/2019 | Thermic Effect of Feeding in Cystic Fibrosis | Thermic Effect of Feeding in Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Boost VHC;Dietary Supplement: Ensure High Protein | Virginia Commonwealth University | NULL | Enrolling by invitation | 18 Years | N/A | All | 10 | N/A | United States |
| 3 | NCT04938726 (ClinicalTrials.gov) | November 1, 2021 | 9/6/2021 | Ketone Supplementation in Cystic Fibrosis | Ketone Monoester Supplementation in Cystic Fibrosis: A Pilot and Feasibility Study | Cystic Fibrosis | Dietary Supplement: Ketone Monoester | University of Alabama at Birmingham | NULL | Recruiting | 18 Years | 89 Years | All | 25 | N/A | United States |
| 4 | NCT04531410 (ClinicalTrials.gov) | July 1, 2021 | 18/8/2020 | NETwork of Linoleic Acid Supplementation in Cystic Fibrosis | Double-blind Randomized Controlled Study of Linoleic Acid Supplementation for 1 Year in Patients With Cystic Fibrosis - Influence on Clinical Status and Metabolism | Cystic Fibrosis | Dietary Supplement: linoleic acid supplementation;Dietary Supplement: oleic acid supplementation | Karolinska Institutet | European Society of Pediatric Gastroenterology, Hepatology and Nutrition | Enrolling by invitation | 5 Years | 15 Years | All | 90 | N/A | Italy;Norway;Poland;Sweden |
| 5 | NCT04496921 (ClinicalTrials.gov) | August 10, 2020 | 21/7/2020 | Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis | Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis : A Pilot Study | Cystic Fibrosis | Dietary Supplement: Vitamin K supplementation, dose #1;Dietary Supplement: Vitamin K supplementation, dose #2 | Institut de Recherches Cliniques de Montreal | Université de Montréal | Withdrawn | 18 Years | N/A | All | 0 | N/A | Canada |
| 6 | NCT04058340 (ClinicalTrials.gov) | July 30, 2019 | 12/8/2019 | Taste Receptors Regulation in CF Patients | The Effects of Taste Receptors Regulation in Upper Airway Innate Immunity of CF Patients | Cystic Fibrosis | Dietary Supplement: lactizole nebulization;Other: Placebo | Medical Universtity of Lodz | NULL | Recruiting | 6 Years | N/A | All | 30 | N/A | Poland |
| 7 | NCT03734744 (ClinicalTrials.gov) | June 17, 2019 | 6/11/2018 | PK/PD of Vitamin D3 in Adults With CF | A Pilot Study Evaluating Single, High-dose Pharmacokinetics/Pharmacodynamics of Vitamin D3 in CF | Vitamin D Deficiency;Cystic Fibrosis | Dietary Supplement: Vitamin D3 | University of Southern California | NULL | Terminated | 18 Years | N/A | All | 6 | N/A | United States |
| 8 | NCT04966897 (ClinicalTrials.gov) | August 31, 2018 | 8/7/2021 | Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis | Randomized, Double-blind, Cross-over Trial Assessing a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Dietary Supplement: GlycosBio Nutritional Supplement + PERT placebo;Dietary Supplement: Standard Nutritional Supplement + PERT | GlycosBio, Inc. | Baylor College of Medicine | Completed | 12 Years | N/A | All | 10 | N/A | United States |
| 9 | NCT03462056 (ClinicalTrials.gov) | May 17, 2018 | 5/3/2018 | Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis | Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food | Washington University School of Medicine | Cystic Fibrosis Foundation | Completed | 2 Years | 12 Years | All | 16 | Phase 1/Phase 2 | United States |
| 10 | NCT03205904 (ClinicalTrials.gov) | December 12, 2016 | 15/6/2017 | Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis. | Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis. | Cystic Fibrosis-related Diabetes;Cystic Fibrosis | Dietary Supplement: Diet | Hospital de Clinicas de Porto Alegre | NULL | Completed | 10 Years | N/A | All | 20 | N/A | Brazil |
| 11 | NCT02810691 (ClinicalTrials.gov) | July 2016 | 14/6/2016 | The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis | The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis | Cystic Fibrosis-related Diabetes;Cystic Fibrosis | Dietary Supplement: Soluble fiber supplementation;Dietary Supplement: Placebo (for fiber supplementation) | Institut de Recherches Cliniques de Montreal | Canadian Cystic Fibrosis Foundation;Université de Montréal | Completed | 18 Years | N/A | All | 14 | N/A | Canada |
| 12 | NCT02646995 (ClinicalTrials.gov) | January 2016 | 22/12/2015 | Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients | Cystic Fibrosis | Dietary Supplement: modified lipid formulation;Dietary Supplement: Fish oil | Nestlé | NULL | Completed | 5 Years | 18 Years | All | 16 | N/A | Switzerland | |
| 13 | NCT02589444 (ClinicalTrials.gov) | December 2015 | 20/10/2015 | Vitamin D and Microbiota in Cystic Fibrosis | Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis | Vitamin D Deficiency;Cystic Fibrosis | Dietary Supplement: High-Dose Vitamin D3;Other: Stool Sample;Other: Sputum Sample;Other: Sham Comparator;Procedure: Blood draw | Emory University | NULL | Completed | 18 Years | N/A | All | 41 | N/A | United States |
| 14 | NCT02518672 (ClinicalTrials.gov) | October 2015 | 3/8/2015 | Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC) | Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis. | Cystic Fibrosis | Dietary Supplement: MAG-DHA;Dietary Supplement: Placebo | SCF Pharma | Centre de recherche du Centre hospitalier universitaire de Sherbrooke;Solutex (Spain) | Terminated | 18 Years | N/A | All | 11 | Phase 2 | Canada |
| 15 | NCT02043717 (ClinicalTrials.gov) | January 2014 | 12/1/2014 | Increased Vitamin D Reduces Pulmonary Exacerbations in CF | Increasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Vitamin D | Hadassah Medical Organization | NULL | Completed | 4 Years | N/A | All | 90 | N/A | Israel |
| 16 | NCT00924547 (ClinicalTrials.gov) | November 2013 | 17/6/2009 | Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis | Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma | Cystic Fibrosis | Dietary Supplement: Docosahexanoic Acid Supplement;Dietary Supplement: Placebo | Vanderbilt University | NULL | Completed | 6 Years | N/A | Both | 17 | Phase 2 | United States |
| 17 | NCT01880346 (ClinicalTrials.gov) | October 2013 | 12/6/2013 | Comparison of Absorption of Vitamin D in Cystic Fibrosis | Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil | Cystic Fibrosis | Dietary Supplement: Vitamin D Powder;Dietary Supplement: Vitamin D Oil | Emory University | NULL | Completed | 18 Years | 59 Years | Both | 17 | Phase 4 | United States |
| 18 | NCT02048592 (ClinicalTrials.gov) | September 2013 | 16/12/2013 | Impact of Immunonutrition on the Patients With Cystic Fibrosis | Impact of Immunonutrition on the Patients With Cystic Fibrosis | Cystic Fibrosis;Malnutrition;Oxidative Stress | Dietary Supplement: Impact-Nutridrink;Dietary Supplement: Nutridrink-Impact | University Hospital, Motol | NULL | Recruiting | 18 Years | 40 Years | Both | 30 | Phase 4 | Czech Republic |
| 19 | NCT01859390 (ClinicalTrials.gov) | June 2013 | 17/5/2013 | Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis | A Multi-Center, Randomized, Controlled, Double-Blind Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: AquADEKs-2;Dietary Supplement: control multivitamin | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Yasoo Health | Completed | 10 Years | N/A | All | 73 | Phase 2 | United States |
| 20 | NCT01837355 (ClinicalTrials.gov) | March 2013 | 10/4/2013 | Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis | Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1) | Pulmonary Inflammation;Cystic Fibrosis;Microbiota | Dietary Supplement: Lactobacillus rhamnosus;Dietary Supplement: Placebo | Cantonal Hospital of St. Gallen | Swiss Federal Institute of Technology;University Hospital Inselspital, Berne | Unknown status | 6 Years | 20 Years | All | 68 | N/A | Switzerland |
| 21 | NCT02014181 (ClinicalTrials.gov) | July 2012 | 27/11/2013 | Flaxseed Modulates Inflammation and Oxidative Stress in CF | Flaxseed Modulates Oxidative Stress and Inflammatory Biomarkers in Stable Patients With Cystic Fibrosis and Healthy Controls | Cystic Fibrosis;Oxidative Stress;Inflammation | Dietary Supplement: finely ground flaxseed powder | University of Pennsylvania | NULL | Completed | 18 Years | 64 Years | Both | 10 | Phase 1 | United States |
| 22 | NCT01417481 (ClinicalTrials.gov) | March 2012 | 15/8/2011 | Effect of Glycine in Cystic Fibrosis | Evaluation of the Capability of a Glycine Oral Supplement for Diminishing Bronchial Inflammation in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Glycine;Dietary Supplement: Placebo | Instituto Nacional de Enfermedades Respiratorias | Hospital Infantil de Mexico Federico Gomez;Instituto Mexicano del Seguro Social | Terminated | 5 Years | 15 Years | All | 13 | Phase 2 | Mexico |
| 23 | NCT02128984 (ClinicalTrials.gov) | January 2012 | 28/3/2014 | Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children | Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children | Cystic Fibrosis;Failure to Thrive;Malnutrition | Dietary Supplement: Symbiotic Formula with DHA and antioxidants;Dietary Supplement: Standard Formula | Laboratorios Ordesa | Quantum Experimental;Peruvian Clinical Research | Completed | 1 Year | N/A | All | 109 | N/A | Peru;Spain |
| 24 | NCT00889434 (ClinicalTrials.gov) | November 1, 2011 | 20/4/2009 | Efficacy and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated Cystic Fibrosis (CF) | Single-site, Open-label, Dose-ranging, Efficacy, and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated CF | Cystic Fibrosis | Dietary Supplement: ECGC;Dietary Supplement: Tocotrienol;Dietary Supplement: EGCG + Tocotrienol | Hadassah Medical Organization | NULL | Completed | 18 Years | N/A | All | 7 | N/A | Israel |
| 25 | NCT01426256 (ClinicalTrials.gov) | October 2011 | 29/8/2011 | Vitamin D for Enhancing the Immune System in Cystic Fibrosis (DISC Study) | Vitamin D for Enhancing the Immune System in Cystic Fibrosis | Cystic Fibrosis;Respiratory Tract Infections | Dietary Supplement: Cholecalciferol | Emory University | Cystic Fibrosis Foundation Therapeutics | Completed | 16 Years | N/A | All | 91 | Phase 3 | United States |
| 26 | NCT01783613 (ClinicalTrials.gov) | October 2011 | 31/1/2013 | Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis | Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months;Dietary Supplement: Placebo: 50 mg/kg/day during 12 months | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | NULL | Completed | 2 Months | 100 Years | All | 96 | N/A | Spain |
| 27 | NCT01772758 (ClinicalTrials.gov) | August 2011 | 16/10/2012 | Cystic Fibrosis and Endothelial Function: At Rest and During Exercise | Influence of Cystic Fibrosis on Vascular Endothelial Function at Rest and During Exercise | Cystic Fibrosis | Drug: BH4 5mg;Drug: BH4 20mg;Dietary Supplement: Antioxidant Cocktail | Augusta University | NULL | Completed | 7 Years | N/A | All | 64 | Phase 2 | United States |
| 28 | NCT01315665 (ClinicalTrials.gov) | April 2011 | 14/3/2011 | Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation | Evaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF Subjects | Cystic Fibrosis | Dietary Supplement: Broccoli sprouts | University Hospitals Cleveland Medical Center | Cystic Fibrosis Foundation | Completed | 18 Years | 49 Years | All | 15 | N/A | United States |
| 29 | NCT02029521 (ClinicalTrials.gov) | March 2011 | 30/12/2013 | Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients | Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis for Growth Failure | Cystic Fibrosis | Dietary Supplement: Oral reduced l-glutathione;Dietary Supplement: Placebo | Clark Bishop | NULL | Completed | 18 Months | 10 Years | All | 47 | N/A | Italy |
| 30 | NCT01494909 (ClinicalTrials.gov) | January 2011 | 15/12/2011 | Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function | Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function | Cystic Fibrosis | Dietary Supplement: Ensure plus | Texas A&M University | Arkansas Children's Hospital Research Institute;University of Arkansas | Active, not recruiting | 10 Years | N/A | All | 31 | N/A | United States |
| 31 | NCT01201434 (ClinicalTrials.gov) | October 2010 | 31/8/2010 | Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis | The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial | Cystic Fibrosis | Dietary Supplement: Bio-25 probiotic | Sheba Medical Center | NULL | Terminated | 5 Years | 40 Years | Both | 12 | N/A | NULL |
| 32 | NCT01956916 (ClinicalTrials.gov) | October 2010 | 23/9/2013 | Probiotics in Cystic Fibrosis | Effects of LGG Administration in Children With Cystic Fibrosis: A Randomized Controlled Trial | Cystic Fibrosis | Dietary Supplement: Lactobacillus rhamnosus GG;Dietary Supplement: placebo | Federico II University | NULL | Completed | 2 Years | 18 Years | Both | 110 | Phase 3 | Italy |
| 33 | NCT01222273 (ClinicalTrials.gov) | September 2010 | 14/10/2010 | Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis | Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis | Cystic Fibrosis;Allergic Bronchopulmonary Aspergillosis | Dietary Supplement: cholecalciferol (Vitamin D3) | University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 12 Years | N/A | All | 7 | N/A | United States |
| 34 | NCT01321905 (ClinicalTrials.gov) | April 2010 | 23/3/2011 | Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis | 5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Supplementation with vitamin D2/D3 | Karolinska Institutet | Stockholm County Council, Sweden;Swedish Cystic Fibrosis Association | Recruiting | 6 Years | N/A | Both | 15 | Phase 2 | Sweden |
| 35 | NCT01051999 (ClinicalTrials.gov) | February 2010 | 15/1/2010 | Glutamine Supplementation in Cystic Fibrosis | Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis | Cystic Fibrosis;Immune Function | Dietary Supplement: Glutamine;Dietary Supplement: L-alanine | Emory University | Emmaus Medical, Inc. | Completed | 18 Years | N/A | Both | 17 | Phase 2 | United States |
| 36 | NCT01961661 (ClinicalTrials.gov) | September 2009 | 9/10/2013 | Probiotics on Intestinal Inflammation in Cystic Fibrosis | Effect of Probiotics on Intestinal Inflammation and Microflora in Cystic Fibrosis: a Pilot Study | Cystic Fibrosis | Dietary Supplement: Lactobacillus rhamnosus GG;Dietary Supplement: placebo | Federico II University | NULL | Completed | 2 Years | 18 Years | Both | 22 | Phase 3 | Italy |
| 37 | NCT01737983 (ClinicalTrials.gov) | May 2009 | 12/7/2012 | Effect of Lactobacillus Reuteri in Cystic Fibrosis | Lactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis. | CYSTIC FIBROSIS | Dietary Supplement: Lactobacillus reuteri;Dietary Supplement: placebo | Azienda Policlinico Umberto I | NULL | Completed | 6 Years | 42 Years | Both | 61 | Phase 4 | Italy |
| 38 | NCT00685971 (ClinicalTrials.gov) | December 2008 | 27/5/2008 | Cholecalciferol for Vitamin D in Adult Cystic Fibrosis (CF) Patients | Randomized Placebo-Controlled Trial of Cholecalciferol for Vitamin D Deficiency in Adults With Cystic Fibrosis | Cystic Fibrosis;Vitamin D Deficiency | Dietary Supplement: 5000 IU of cholecalciferol;Dietary Supplement: placebo | St. Michael's Hospital, Toronto | NULL | Completed | 18 Years | N/A | Both | 200 | N/A | Canada |
| 39 | NCT00959010 (ClinicalTrials.gov) | October 2008 | 13/8/2009 | Omega 3 Supplementation in Cystic Fibrosis Patients | Biochemical Effects of a Long-term Supplementation With Omega-3 Polyunsaturated Fatty Acids in Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: omega-3 triglycerides;Dietary Supplement: Placebo | Queen Fabiola Children's University Hospital | NULL | Completed | 6 Years | 60 Years | Both | 15 | Phase 3 | Belgium |
| 40 | NCT00788138 (ClinicalTrials.gov) | October 2008 | 7/11/2008 | Effects of Vitamin D Supplementation on Lung Function in an Acute Pulmonary Exacerbation of Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Vitamin D3;Dietary Supplement: Placebo | Emory University | NULL | Completed | 18 Years | 70 Years | Both | 30 | N/A | United States | |
| 41 | NCT01172301 (ClinicalTrials.gov) | July 2008 | 27/7/2010 | Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis | Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Essential amino acid intake + Leucine vs total AA supplement | Texas A&M University | Arkansas Children's Hospital Research Institute | Completed | 10 Years | 21 Years | Both | 14 | N/A | United States |
| 42 | NCT00762918 (ClinicalTrials.gov) | March 2008 | 26/9/2008 | Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis | Vitamin D and Its Non-Classic Roles in Cystic Fibrosis | Cystic Fibrosis;Vitamin D Deficiency | Dietary Supplement: cholecalciferol | Children's Hospital of Philadelphia | NULL | Withdrawn | 10 Years | 25 Years | Both | 0 | Phase 3 | United States |
| 43 | NCT01070446 (ClinicalTrials.gov) | October 2007 | 10/2/2010 | Choline Nutrition in Children With Cystic Fibrosis | Choline Nutrition in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Vitamin: Choline Bitartrate (2-hydroxyethyl) trimethylammonium salt 1:1 | University of British Columbia | Cystic Fibrosis Foundation (US) | Completed | 5 Years | 17 Years | Both | 34 | N/A | Canada |
| 44 | NCT01018303 (ClinicalTrials.gov) | August 2007 | 19/11/2009 | Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic Fibrosis | Safety and Efficacy of a Novel Antioxidant-rich Multivitamin Supplement for Persons With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: AquADEK | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Yasoo Health;National Institutes of Health (NIH) | Completed | 10 Years | 40 Years | Both | 17 | Phase 1/Phase 2 | United States |
| 45 | NCT00406536 (ClinicalTrials.gov) | January 2007 | 29/11/2006 | Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI | Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF | Cystic Fibrosis;Pancreatic Insufficiency | Dietary Supplement: Lym-X-Sorb powder;Dietary Supplement: Placebo powder | Avanti Polar Lipids, Inc. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 6 Years | 17 Years | Both | 110 | Phase 2 | United States |
| 46 | NCT00730509 (ClinicalTrials.gov) | April 2004 | 4/8/2008 | Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis | Preliminary Evidences of Active Form of Folic Acid and Vitamin B12 Supplementation to Ameliorate Cell Membrane in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: 5-methyltetrahydrofolate and vitamin B12 | Universita di Verona | NULL | Completed | 3 Years | 8 Years | Both | 31 | N/A | Italy |
| 47 | NCT00530244 (ClinicalTrials.gov) | March 2003 | 13/9/2007 | Use of Formula Fortified With DHA in Infants With Cystic Fibrosis | The Effect of Formula Fortified With Docosahexaenoic Acid (DHA) on Infants With Cystic Fibrosis (CF) | Cystic Fibrosis | Dietary Supplement: Docosahexaenoic acid (DHA);Dietary Supplement: Standard formula (Enfamil) | University of Massachusetts, Worcester | Cystic Fibrosis Foundation | Completed | N/A | 56 Days | All | 76 | N/A | United States |