Sulfate ( DrugBank: Sulfate )
27 diseases
ID | Disease name (Link within this page) | Number of trials |
---|---|---|
2 | Amyotrophic lateral sclerosis | 4 |
3 | Spinal muscular atrophy | 1 |
6 | Parkinson disease | 1 |
11 | Myasthenia gravis | 2 |
13 | Multiple sclerosis/Neuromyelitis optica | 6 |
26 | HTLV-1-associated myelopathy | 2 |
28 | Systemic amyloidosis | 1 |
34 | Neurofibromatosis | 19 |
36 | Epidermolysis bullosa | 5 |
46 | Malignant rheumatoid arthritis | 8 |
49 | Systemic lupus erythematosus | 2 |
53 | Sjogren syndrome | 7 |
60 | Aplastic anemia | 1 |
64 | Thrombotic thrombocytopenic purpura | 1 |
66 | IgA nephropathy | 3 |
85 | Idiopathic interstitial pneumonia | 2 |
86 | Pulmonary arterial hypertension | 1 |
96 | Crohn disease | 1 |
111 | Congenital myopathy | 2 |
218 | Alport syndrome | 1 |
222 | Primary nephrotic syndrome | 1 |
224 | Purpura nephritis | 1 |
226 | Interstitial cystitis with Hunners ulcer | 4 |
265 | Lipodystrophy | 3 |
296 | Biliary atresia | 1 |
297 | Alagille syndrome | 1 |
299 | Cystic fibrosis | 35 |
2. Amyotrophic lateral sclerosis
Clinical trials : 645 / Drugs : 589 - (DrugBank : 163) / Drug target genes : 150 - Drug target pathways : 225
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 | NCT03883581 (ClinicalTrials.gov) | July 25, 2019 | 12/3/2019 | Impact of Nuedexta on Bulbar Physiology and Function in ALS | Impact of Nuedexta on Bulbar Physiology and Function in ALS | Amyotrophic Lateral Sclerosis | Drug: dextromethorphan HBr and quinidine sulfate | University of Florida | Holy Cross Hospital, Florida;ALS Association | Completed | 18 Years | 90 Years | All | 28 | Phase 1/Phase 2 | United States |
2 | EUCTR2018-000668-28-GB (EUCTR) | 09/08/2018 | 25/06/2018 | A study to assess safety and acceptability of a treatment in patients with ALS | A Phase II pilot safety and tolerability study of ILB in patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) - The ALS Study | Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ILB: 100mg/ml solution for injection and infusion INN or Proposed INN: Dextran Sodium Sulfur Salt 5, Mw 5 kDa. a type of Low Molecular Weight Dextran Sulfate (LMW-DS) Other descriptive name: ILB | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
3 | EUCTR2017-005065-47-SE (EUCTR) | 15/05/2018 | 19/03/2018 | A single-center, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis. | A single-centre, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILB Product Code: ILB INN or Proposed INN: ILB Other descriptive name: DEXTRAN SULFATE SODIUM | TikoMed AB | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Sweden | ||
4 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |
3. Spinal muscular atrophy
Clinical trials : 237 / Drugs : 123 - (DrugBank : 29) / Drug target genes : 51 - Drug target pathways : 75
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 | ChiCTR2000041208 | 2020-12-30 | 2020-12-22 | A randomized, double-blind, placebo parallel controlled clinical trial on the efficacy and safety of salbutamol sulfate tablets in the treatment of children with spinal muscular atrophy | A randomized, double-blind, placebo parallel controlled clinical trial on the efficacy and safety of salbutamol sulfate tablets in the treatment of children with spinal muscular atrophy | spinal muscular atrophy | experimental group: salbutamol sulfate tablets ;control group:placebo; | The Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 2 | 17 | Both | experimental group:60;control group:30; | Phase 4 | China |
6. Parkinson disease
Clinical trials : 2,307 / Drugs : 2,007 - (DrugBank : 349) / Drug target genes : 188 - Drug target pathways : 199
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 | NCT01313845 (ClinicalTrials.gov) | February 2011 | 10/3/2011 | Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease | Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease | Parkinson's Disease | Drug: amantadine sulfate;Drug: 0.9% sodium chloride | Jee-Young Lee | Seoul National University Boramae Hospital;Samsung Medical Center;Seoul National University Bundang Hospital;Hanyang University | Completed | 30 Years | 79 Years | Both | 46 | Phase 4 | Korea, Republic of |
11. Myasthenia gravis
Clinical trials : 332 / Drugs : 234 - (DrugBank : 81) / Drug target genes : 45 - Drug target pathways : 127
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 | EUCTR2019-000895-40-DK (EUCTR) | 28/03/2019 | 26/02/2019 | Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis | Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis - BETA-MG | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Salbutamol WZF 4 mg INN or Proposed INN: Salbutamol Other descriptive name: SALBUTAMOL SULFATE PH. EUR. | Aarhus University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Denmark | ||
2 | ChiCTR1800017696 | 2016-07-01 | 2018-08-10 | Effect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia Gravis | Effect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia Gravis | Myasthenia Gravis | Group A:Magnesium Sulfate;Group B:Normal saline; | The University of Hong Kong-Shenzhen Hospital | NULL | Recruiting | 18 | 60 | Both | Group A:30;Group B:30; | China |
13. Multiple sclerosis/Neuromyelitis optica
Clinical trials : 3,340 / Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
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 | EUCTR2022-003170-23-FI (EUCTR) | 20/12/2022 | 30/09/2022 | Hydroxychloroquine in progressive MS | Prospective, randomized, double-blind, placebo-controlled, single-center comparative trial evaluating oral hydroxychloroquine 200 mg BID for reducing microglial activation in the brain of patients with progressive multiple sclerosis (MS) | Progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Oxiklorin Product Name: Oxiklorin INN or Proposed INN: Hydroxychloroquine sulfate | Varsinais-Suomen sairaanhoitopiirin kuntayhtymä | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Finland | ||
2 | EUCTR2011-002178-22-GB (EUCTR) | 27/04/2012 | 29/03/2012 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
3 | EUCTR2011-002178-22-PL (EUCTR) | 20/03/2012 | 25/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 15.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
4 | EUCTR2011-002178-22-CZ (EUCTR) | 08/02/2012 | 02/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
5 | NCT01615887 (ClinicalTrials.gov) | November 2009 | 23/3/2011 | Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis | Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis | Multiple Sclerosis | Drug: lisdexamfetamine sulfate;Drug: placebo | State University of New York at Buffalo | NULL | Completed | 18 Years | 55 Years | Both | 63 | Phase 2 | United States |
6 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |
26. HTLV-1-associated myelopathy
Clinical trials : 29 / Drugs : 47 - (DrugBank : 29) / Drug target genes : 34 - Drug target pathways : 119
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 | NCT04301076 (ClinicalTrials.gov) | June 15, 2020 | 6/3/2020 | Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment (EPOCH) for Adult T-Cell Leukemia-Lymphoma (ATL) | A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL) | Acute Adult T-Cell Leukemia/Lymphoma;Adult T-Cell Leukemia/Lymphoma;Chronic Adult T-Cell Leukemia/Lymphoma;HTLV-1 Infection | Drug: Cyclophosphamide;Drug: Doxorubicin Hydrochloride;Drug: Etoposide;Drug: Lenalidomide;Drug: Prednisone;Drug: Vincristine Sulfate | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 1 | United States |
2 | NCT00041327 (ClinicalTrials.gov) | October 2002 | 8/7/2002 | Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma | Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma | Lymphoma | Biological: filgrastim;Biological: recombinant interferon alfa;Drug: Etoposide;Drug: cyclophosphamide;Drug: doxorubicin hydrochloride;Drug: lamivudine;Drug: prednisone;Drug: vincristine sulfate;Drug: zidovudine | AIDS Malignancy Consortium | National Cancer Institute (NCI) | Completed | 18 Years | 120 Years | Both | 19 | Phase 2 | United States |
28. Systemic amyloidosis
Clinical trials : 267 / Drugs : 241 - (DrugBank : 77) / Drug target genes : 68 - Drug target pathways : 180
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 | EUCTR2011-001787-22-IT (EUCTR) | 02/05/2012 | 12/01/2012 | Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis. | An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex | Previously treated AL amyloidosis MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: pomalidomide Product Code: CC-4047 INN or Proposed INN: Pomalidomide INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE | OSPEDALE POLICLINICO S. MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Italy |
34. Neurofibromatosis
Clinical trials : 133 / Drugs : 186 - (DrugBank : 67) / Drug target genes : 79 - Drug target pathways : 190
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 | EUCTR2020-005608-20-ES (EUCTR) | 16/02/2022 | 19/10/2021 | Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) | A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE | Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify | Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 10mg Product Name: Selumetinib capsules 10mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 25mg Product Name: Selumetinib capsules 25mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 38 | Phase 1;Phase 2 | United States;Spain;Russian Federation;Netherlands;Germany;Italy | ||
2 | EUCTR2020-005607-39-PL (EUCTR) | 25/01/2022 | 14/09/2021 | Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas | A Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET) - KOMET | Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Selumetinib 10mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib 25mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 146 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Australia;Netherlands;Germany;China;Japan | ||
3 | EUCTR2020-005608-20-NL (EUCTR) | 24/01/2022 | 21/10/2021 | Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) | A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE | Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify | Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 10mg Product Name: Selumetinib capsules 10mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 25mg Product Name: Selumetinib capsules 25mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 38 | Phase 1;Phase 2 | United States;Spain;Russian Federation;Germany;Netherlands;Italy | ||
4 | EUCTR2020-005608-20-DE (EUCTR) | 24/11/2021 | 09/09/2021 | Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) | A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE | Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify | Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib capsules 10mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib capsules 25mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 1;Phase 2 | United States;Spain;Russian Federation;Netherlands;Germany;Italy;Japan | ||
5 | EUCTR2020-005607-39-ES (EUCTR) | 05/10/2021 | 23/06/2021 | Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas | A Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET) - KOMET | Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Selumetinib 10mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib 25mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 146 | Phase 3 | United States;Spain;Russian Federation;Italy;France;Canada;Brazil;Poland;Australia;Germany;Netherlands;China;Japan | ||
6 | EUCTR2020-005607-39-IT (EUCTR) | 08/09/2021 | 18/10/2021 | Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas | A Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET). - KOMET | Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Selumetinib 25mg capsule Product Code: [AZD6244] INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib 10mg capsule Product Code: [AZD6244] INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 146 | Phase 3 | United States;Spain;Russian Federation;Italy;France;Canada;Brazil;Poland;Australia;Germany;Netherlands;China;Japan | ||
7 | EUCTR2020-005648-52-PL (EUCTR) | 31/05/2021 | 26/04/2021 | Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Toxicity of Selumetinib in Adolescent Children with Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) | A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Toxicity and Pharmacokinetics of Selumetinib after Multiple Doses in Adolescent Children with Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) - Selumetinib Gastrointestinal Toxicity Study (Selumetinib GI Tox Study) | Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify | Trade Name: Koselugo 10mg Product Name: Selumetinib 10mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 25mg Product Name: Selumetinib 25mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1 | United States;Spain;Poland;Russian Federation | ||
8 | NCT04166409 (ClinicalTrials.gov) | January 3, 2020 | 15/11/2019 | A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma | A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1) | Low Grade Astrocytoma;Low Grade Glioma;Metastatic Low Grade Astrocytoma;Metastatic Low Grade Glioma | Procedure: Biospecimen Collection;Drug: Carboplatin;Procedure: Magnetic Resonance Imaging;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: Selumetinib Sulfate;Drug: Vincristine Sulfate | National Cancer Institute (NCI) | NULL | Recruiting | 2 Years | 21 Years | All | 220 | Phase 3 | United States;Canada;Puerto Rico |
9 | NCT03871257 (ClinicalTrials.gov) | October 4, 2019 | 11/3/2019 | A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma | A Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG) | Low Grade Glioma;Neurofibromatosis Type 1;Visual Pathway Glioma | Drug: Carboplatin;Procedure: Magnetic Resonance Imaging;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: Selumetinib Sulfate;Drug: Vincristine Sulfate | National Cancer Institute (NCI) | NULL | Recruiting | 2 Years | 21 Years | All | 290 | Phase 3 | United States;Canada;Puerto Rico |
10 | NCT03433183 (ClinicalTrials.gov) | October 2, 2019 | 29/1/2018 | SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors | SARC031: A Phase 2 Trial of the MEK Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Combination With the mTOR Inhibitor Sirolimus for Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumors | Malignant Peripheral Nerve Sheath Tumors;Neurofibromatosis 1 | Drug: Selumetinib;Drug: Sirolimus | Sarcoma Alliance for Research through Collaboration | United States Department of Defense;AstraZeneca | Active, not recruiting | 12 Years | N/A | All | 21 | Phase 2 | United States |
11 | EUCTR2017-002635-41-GB (EUCTR) | 26/09/2018 | 19/06/2019 | A PAEDIATRIC PHASE I/II STUDY OF INTERMITTENT DOSING OF THE MEK-1 INHIBITOR SELUMETINIB IN CHILDREN WITH NEUROFIBROMATOSIS TYPE-1 AND INOPERABLE PLEXIFORM NEUROFIBROMA AND/OR PROGRESSIVE OPTIC PATHWAY GLIOMA | A paediatric phase I/II study of intermittent dosing of the MEK-1 inhibitor selumetinib in children with neurofibromatosis type-1 and inoperable plexiform neurofibroma and/or progressive optic pathway glaiom - Intermittent Selumetinib dosing Phase I/II study Childhood NF1 tumours | Neurofibromatosis type 1 associated plexiform neurofibromas Neurofibromatosis type 1 associated progressive or relapsed optic pathway glioma MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10065866;Term: Plexiform neurofibroma;System Organ Class: 100000004864 MedDRA version: 20.0;Classification code 10030935;Term: Optic nerve glioma;System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Selumetinib INN or Proposed INN: selumetinib sulfate Other descriptive name: Selumetinib Hyd-sulphate | Great Ormond Street Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 38 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
12 | NCT03105258 (ClinicalTrials.gov) | May 1, 2017 | 23/3/2017 | Selumetinib Pilot Study for Cutaneous Neurofibromas | Pilot Study of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) for Adults With Neurofibromatosis Type 1 (NF1) and Cutaneous Neurofibromas (cNF) | Neurofibromatosis Type 1;Cutaneous Neurofibroma | Drug: Selumetinib | University of Alabama at Birmingham | National Cancer Institute (NCI) | Not yet recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States |
13 | NCT02839720 (ClinicalTrials.gov) | April 11, 2017 | 20/7/2016 | Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous Neurofibroma | Pilot Study of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) for Adults With Neurofibromatosis Type 1 (NF1) and Cutaneous Neurofibromas (CNF) | Cutaneous Neurofibroma;Neurofibromatosis Type 1;Optic Nerve Glioma | Other: Laboratory Biomarker Analysis;Drug: Selumetinib Sulfate | National Cancer Institute (NCI) | NULL | Active, not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States |
14 | NCT03109301 (ClinicalTrials.gov) | April 7, 2017 | 11/4/2017 | Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in People With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST) | A Phase II Trial of the Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Patients With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST) | Neoplasms, Nerve Tissue;Neurofibromatosis 1;Heredodegenerative Disorders, Nervous System;Peripheral Nervous System Diseases | Drug: Selumetinib (AZD6244 hyd sulfate) 50mg/dose;Drug: Selumetinib (AZD6244 hyd sulfate) 25mg/m2 | National Cancer Institute (NCI) | NULL | Withdrawn | 3 Years | 99 Years | All | 0 | Phase 2 | United States |
15 | NCT02407405 (ClinicalTrials.gov) | January 7, 2016 | 2/4/2015 | MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas | Phase II Trial of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas | Neurofibromatosis 1 (NF1);Plexiform Neurofibromas (PN) | Drug: Selumetinib | National Cancer Institute (NCI) | NULL | Active, not recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
16 | NCT02644512 (ClinicalTrials.gov) | December 2015 | 31/12/2015 | MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas | Phase II Trial of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas | Neurofibromatosis 1;Plexiform Neurofibromas | Drug: Selumetinib | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | 99 Years | Both | 50 | Phase 2 | United States |
17 | NCT01362803 (ClinicalTrials.gov) | September 21, 2011 | 27/5/2011 | AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors | A Phase I/II Study of the Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor Selumetinib (AZD6244; Hydrogen Sulfate in Children With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN) | Neurofibromatosis 1;Neurofibromatosis Type 1;NF1;Neurofibroma, Plexiform | Drug: AZD6244 | National Cancer Institute (NCI) | NULL | Active, not recruiting | 2 Years | 18 Years | All | 99 | Phase 1/Phase 2 | United States |
18 | NCT00846430 (ClinicalTrials.gov) | October 2008 | 16/1/2009 | Medical Treatment of High-Risk Neurofibromas | Medical Treatment of High-Risk Neurofibromas in Patients With Type 1 Neurofibromatosis: A Clinical Trial of Sequential Medical Therapies | Neurofibromatosis 1 | Drug: Peg-Interferon alpha-2b;Drug: Celecoxib (Celebrex);Drug: Temozolomide (temodar);Drug: Vincristine Sulfate (Oncovin) | Spectrum Health Hospitals | NULL | Completed | 2 Years | 30 Years | All | 11 | Phase 2 | United States |
19 | NCT00352495 (ClinicalTrials.gov) | June 2006 | 13/7/2006 | Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma | A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas | Brain and Central Nervous System Tumors;Neurofibromatosis Type 1 | Drug: carboplatin;Drug: vinblastine sulfate | Children's Oncology Group | National Cancer Institute (NCI) | Completed | N/A | 21 Years | Both | 26 | Phase 1 | United States;Canada |
36. Epidermolysis bullosa
Clinical trials : 163 / Drugs : 185 - (DrugBank : 46) / Drug target genes : 50 - Drug target pathways : 125
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 | NCT04644627 (ClinicalTrials.gov) | December 1, 2020 | 20/11/2020 | Topical Gentamicin Nonsense Suppression Therapy of EB | TOPICAL GENTAMICIN TREATMENT OF PATIENTS WITH EPIDERMOLYSIS BULLOSA DUE TO NONSENSE MUTATIONS | Epidermolysis Bullosa | Drug: Gentamicin Sulfate | Oslo University Hospital | NULL | Completed | N/A | N/A | All | 4 | Phase 1/Phase 2 | Norway |
2 | EUCTR2020-002337-15-NO (EUCTR) | 16/09/2020 | 29/06/2020 | TOPICAL GENTAMICIN TREATMENT OF PATIENTS WITH EPIDERMOLYSIS BULLOSA | TOPICAL GENTAMICIN TREATMENT OF PATIENTS WITH EPIDERMOLYSIS BULLOSA DUE TO NONSENSE MUTATIONS (THE GENTELBULL STUDY) - GENTELBULL | Epidermolysis bullosa caused by nonsense mutations or splice site mutations;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Infectogenta Product Name: Gentamicin sulfate 0.1% ointment | Oslo University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Norway | ||
3 | NCT04140786 (ClinicalTrials.gov) | October 31, 2019 | 23/10/2019 | Optimizing IV Gentamicin in JEB | Optimization of Intravenous Gentamicin Treatment to Restore Functional Laminin 332 in JEB Patients With Nonsense Mutations | Junctional Epidermolysis Bullosa | Drug: Gentamicin Sulfate, Injectable | University of Southern California | NULL | Recruiting | 30 Days | N/A | All | 6 | Phase 1/Phase 2 | United States |
4 | NCT03526159 (ClinicalTrials.gov) | June 1, 2018 | 17/4/2018 | Gentamicin for Junctional Epidermolysis Bullosa | A Pilot Study of the Restoration of Functional Laminin 332 in JEB Patients With Nonsense Mutations After Topical and Intravenous Gentamicin Treatment | Junctional Epidermolysis Bullosa | Drug: Gentamicin Sulfate | University of Southern California | NULL | Recruiting | N/A | N/A | All | 6 | Phase 1/Phase 2 | United States |
5 | NCT03012191 (ClinicalTrials.gov) | February 2, 2017 | 4/1/2017 | Gentamicin for RDEB | Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa Patients With Nonsense Mutations | Recessive Dystrophic Epidermolysis Bullosa | Drug: Gentamicin Sulfate | University of Southern California | NULL | Completed | N/A | N/A | All | 6 | Phase 1/Phase 2 | United States |
46. Malignant rheumatoid arthritis
Clinical trials : 4,356 / Drugs : 2,567 - (DrugBank : 415) / Drug target genes : 192 - Drug target pathways : 228
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 | EUCTR2015-000538-31-DE (EUCTR) | 01/06/2015 | 07/04/2015 | Application into the joint of opioids in chronic arthritis of the knee joint | NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint | chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA. MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Morphine Hexal INN or Proposed INN: Morphinsulfat Other descriptive name: MORPHINE SULFATE Trade Name: Triam 40 mg Lichtenstein INN or Proposed INN: TRIAMCINOLONACETONID Other descriptive name: TRIAMCINOLONACETONID EP | Charité University medicine Berlin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
2 | EUCTR2011-004720-35-NO (EUCTR) | 04/05/2015 | 26/01/2015 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Norway;Sweden | ||
3 | EUCTR2011-004720-35-FI (EUCTR) | 10/09/2014 | 09/09/2014 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland;Denmark;Sweden | |||
4 | ChiCTR-TRC-14004520 | 2014-05-01 | 2014-04-13 | To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water | To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water metabolism | rheumatoid arthritis | two:Methotrexate, hydroxychloroquine sulfate pills and NSAIDs in both groups; Sanhuang Yinong decoction will be give in the experimental group;RA patients:NA; | General Hospital of Chengdu Military Region | NULL | Recruiting | 45 | 65 | Both | two:240;RA patients:40; | I (Phase 1 study) | China |
5 | EUCTR2013-003658-26-NL (EUCTR) | 13/11/2013 | 18/10/2013 | Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study | Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study | Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Prednison Product Name: Prednison INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Plaquenil Product Name: hydroxycholoquine INN or Proposed INN: hydroxychloroquine sulfate Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Sulfasalazine Product Name: Sulfasalazine INN or Proposed INN: Sulfasalazine Other descriptive name: SULFASALAZINE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
6 | EUCTR2009-015740-42-DE (EUCTR) | 12/05/2010 | 12/01/2010 | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: A | Universitätsklinkum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 3 | Germany | ||
7 | ChiCTR2100043373 | 2009-07-01 | 2021-02-12 | Clinical study of Hydroxychloroquine Sulfate and sulfasalazine in the treatment of active rheumatoid arthritis | Clinical study of Hydroxychloroquine Sulfate and sulfasalazine in the treatment of active rheumatoid arthritis | rheumatoid arthritis | group one:HCQ(200mg/d)+MTX;group two:HCQ(400mg/d)+MTX;group three:HCQ(200mg/d)+SASP+MTX;group four:SASP+MTX; | Renji Hospital, Shanghai Jiaotong University School of Medicine | NULL | Completed | Both | group one:50;group two:50;group three:50;group four:50; | Phase 4 | china | ||
8 | EUCTR2006-006186-16-NL (EUCTR) | 30/01/2007 | 16/07/2007 | IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED | IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED | rheumatoid arthritis and undifferentiated arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Methotrexate Product Code: MTX INN or Proposed INN: METHOTREXATE Product Name: Prednisone INN or Proposed INN: PREDNISONE Product Name: Sulfasalazine INN or Proposed INN: SULFASALAZINE Trade Name: hydroxychloroquine Product Name: hydroxychloroquine Product Code: HCQ INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE Trade Name: Humira Product Name: adalimumab | Leiden University Medical Center, department of rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands |
49. Systemic lupus erythematosus
Clinical trials : 993 / Drugs : 702 - (DrugBank : 184) / Drug target genes : 116 - Drug target pathways : 200
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 | ChiCTR1800019308 | 2018-11-12 | 2018-11-04 | Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus | Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus | systemic lupus erythematosus | NHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l); | The Third Affiliated Hospital, Southern Medical University | NULL | Recruiting | 18 | 65 | Both | NHMX:75;control:75; | China | |
2 | NCT01551069 (ClinicalTrials.gov) | March 2012 | 8/3/2012 | Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion | A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion | Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus | Drug: hydroxychloroquine (Z0188);Drug: Placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 103 | Phase 3 | Japan |
53. Sjogren syndrome
Clinical trials : 305 / Drugs : 325 - (DrugBank : 104) / Drug target genes : 58 - Drug target pathways : 188
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 | EUCTR2019-002470-32-NL (EUCTR) | 12/12/2022 | 23/07/2021 | NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients | NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY | Primary Sjögren’s syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PLAQUENIL Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil INN or Proposed INN: Mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Arava Product Name: Leflunomide INN or Proposed INN: LEFLUNOMIDE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Netherlands;Italy | ||
2 | ChiCTR2200057578 | 2022-03-01 | 2022-03-15 | Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial | Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial | Sjogren Syndrome | Control group:Same dose of hydroxychloroquine sulfate as before;Intervention group:Tofacitinib 5mg bid po+the same dose of hydroxychloroquine sulfate as before; | Ningbo Medical Center Lihuili Hospital | NULL | Pending | 15 | 70 | Both | Control group:60;Intervention group:60; | Phase 4 | China |
3 | EUCTR2019-002470-32-NO (EUCTR) | 14/12/2021 | 26/08/2021 | NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients | NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY | Primary Sjögren’s syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PLAQUENIL Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil INN or Proposed INN: Mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Arava Product Name: Leflunomide INN or Proposed INN: LEFLUNOMIDE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Netherlands;Norway;Italy | ||
4 | EUCTR2019-002470-32-IT (EUCTR) | 05/10/2021 | 27/01/2022 | Nuovi end-points clinici in pazienti con sindrome di Sjögren primaria (pSS): uno studio interventistico basato sulla stratificazione dei pazienti. | NEw Clinical End-points in patients with primary Sjögren's Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY | Primary Sjögren's syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Arava Product Name: Leflunomide Product Code: [Leflunomide] INN or Proposed INN: LEFLUNOMIDE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil Product Code: [mycophenolate mofetil] INN or Proposed INN: MICOFENOLATO MOFETILE Trade Name: PLAQUENIL Product Name: Hydroxychloroquine Product Code: [Hydroxychloroquine] INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE | ASSITANCE PUBLIQUE DES HOPITAUX DE PARIS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;Greece;Spain;Norway;Netherlands;United Kingdom;Italy;Sweden | ||
5 | ITMCTR2000003900 | 2020-09-08 | 2020-09-08 | Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial | Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial | Primary Sjogren's syndrome | Control group:Hydroxychloroquine sulfate tablets 200ml bid po;Experimental group:Bushen Qingre Runzao Decoction 200ml bid po; | China-Japan Friendship Hospital | NULL | Recruiting | 18 | 75 | Both | Control group:48;Experimental group:48; | N/A | China |
6 | ChiCTR2000037989 | 2020-09-08 | 2020-09-08 | Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial | Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial | Primary Sjogren's syndrome | Experimental group:Bushen Qingre Runzao Decoction 200ml bid po;Control group:Hydroxychloroquine sulfate tablets 200ml bid po; | China-Japan Friendship Hospital | NULL | Recruiting | 18 | 75 | Both | Experimental group:48;Control group:48; | N/A | China |
7 | EUCTR2007-005218-38-FR (EUCTR) | 31/01/2008 | 20/11/2007 | Essai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUER | Essai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUER | Syndrome de Sjögren primitif MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's | Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Sulfate d'hydroxychloroquine | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France |
60. Aplastic anemia
Clinical trials : 245 / Drugs : 318 - (DrugBank : 86) / Drug target genes : 44 - Drug target pathways : 166
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 | EUCTR2011-005152-34-ES (EUCTR) | 26/03/2012 | 22/11/2011 | Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia). | Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropenia | In-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis. MedDRA version: 14.0;Level: PT;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0;Level: LLT;Classification code 10066156;Term: Empiric treatment;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | INN or Proposed INN: ACICLOVIR Other descriptive name: ACICLOVIR INN or Proposed INN: AMIKACIN Other descriptive name: AMIKACIN INN or Proposed INN: AMPHOTERICINE B, LIPOSOME Other descriptive name: AMPHOTERICINE B, LIPOSOME INN or Proposed INN: CASPOFUNGIN ACETATE Other descriptive name: CASPOFUNGIN ACETATE INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: CIPROFLOXACIN Other descriptive name: CIPROFLOXACIN INN or Proposed INN: TRIMETHOPRIM SULFATE Other descriptive name: TRIMETHOPRIM SULFATE INN or Proposed INN: SULFAMETH | José Miguel Cisneros Herreros | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain |
64. Thrombotic thrombocytopenic purpura
Clinical trials : 92 / Drugs : 85 - (DrugBank : 21) / Drug target genes : 18 - Drug target pathways : 76
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 | NCT03237819 (ClinicalTrials.gov) | May 27, 2018 | 13/6/2017 | Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care | Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled Trial | Thrombotic Thrombocytopenic Purpura | Drug: Sulfate, Magnesium;Drug: Placebo - Concentrate | Assistance Publique - Hôpitaux de Paris | NULL | Active, not recruiting | 18 Years | N/A | All | 74 | Phase 3 | France |
66. IgA nephropathy
Clinical trials : 275 / Drugs : 258 - (DrugBank : 82) / Drug target genes : 36 - Drug target pathways : 140
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 | NCT02942381 (ClinicalTrials.gov) | September 13, 2016 | 14/10/2016 | A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy | IgA Patients;Hydroxychloroquine | Drug: Hydroxychloroquine Sulfate;Drug: Placebo | Peking University First Hospital | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 2 | China | |
2 | NCT02765594 (ClinicalTrials.gov) | June 2016 | 30/4/2016 | Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy | Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled Study | Primary IgA Nephropathy | Drug: Hydroxychloroquine Sulfate;Drug: Valsartan | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 60 Years | All | 98 | Phase 4 | China |
3 | NCT02351752 (ClinicalTrials.gov) | January 2015 | 27/1/2015 | Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study | Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal Disease | Primary IgA Nephropathy | Drug: Hydroxychloroquine Sulfate | LLiu | NULL | Completed | 18 Years | 75 Years | Both | 20 | Phase 4 | China |
85. Idiopathic interstitial pneumonia
Clinical trials : 627 / Drugs : 443 - (DrugBank : 120) / Drug target genes : 99 - Drug target pathways : 212
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 | NCT04429516 (ClinicalTrials.gov) | December 17, 2020 | 12/3/2020 | Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough | PAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis Cough | Idiopathic Pulmonary Fibrosis | Drug: Morphine Sulfate;Drug: Placebo oral tablet | Royal Brompton & Harefield NHS Foundation Trust | NULL | Recruiting | 40 Years | 90 Years | All | 44 | Phase 3 | United Kingdom |
2 | EUCTR2019-003571-19-GB (EUCTR) | 21/05/2020 | 27/02/2020 | A multicentre, double blind, placebo controlled, crossover trial of morphine sulphate sulfate for the treatment of PulmonAry Fibrosis Cough (PAciFy Cough Trial) | PAciFy Cough: A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough - PACIFY Cough | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Morphine Sulfate Product Name: Morphine Sulfate INN or Proposed INN: morphine sulfate | Royal Brompton and Harefield NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 3 | United Kingdom |
86. Pulmonary arterial hypertension
Clinical trials : 1,205 / Drugs : 684 - (DrugBank : 124) / Drug target genes : 100 - Drug target pathways : 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 | NCT03401476 (ClinicalTrials.gov) | May 8, 2017 | 30/4/2017 | Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension | Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Morphine Sulfate | John Granton | NULL | Unknown status | 18 Years | N/A | All | 15 | Phase 2 | Canada |
96. Crohn disease
Clinical trials : 2,442 / Drugs : 1,278 - (DrugBank : 248) / Drug target genes : 142 - Drug target pathways : 209
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 | NCT01245088 (ClinicalTrials.gov) | January 2011 | 19/11/2010 | Chondroitin Sulfate for Crohn's Disease | A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease | Crohn's Disease | Drug: chondroitin sulfate | University Hospital Case Medical Center | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 1/Phase 2 | United States |
111. Congenital myopathy
Clinical trials : 10 / Drugs : 17 - (DrugBank : 5) / Drug target gene : 1 - Drug target pathways : 9
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 | NCT05099107 (ClinicalTrials.gov) | October 25, 2021 | 15/10/2021 | Changes of Motor Function Tests in Congenital Myopathy Subjects Treated With Oral Salbutamol as Compared to no Treatment | COMPIS- Congenital Myopathy Intervention Study. An Open-label, Cross Over, Randomised, Controlled Study Using Oral Salbutamol | Congenital Myopathy;Neuromuscular Diseases;Musculoskeletal Diseases;Nemaline Myopathy;Centronuclear Myopathy;Myosin Storage Myopathy | Drug: Salbutamol (as Salbutamol Sulfate) 2 Mg Oral Tablet;Drug: Salbutamol Only Product in Oral Dose Form | Vastra Gotaland Region | NULL | Enrolling by invitation | 6 Years | 30 Years | All | 20 | N/A | Sweden |
2 | EUCTR2019-001147-51-SE (EUCTR) | 31/03/2020 | 27/09/2019 | This is a treatment study for a muscle disorder known as congenital myopathy | Congenital myopathy intervention study - COMPIS | Congenital myopathy MedDRA version: 20.0;Level: PT;Classification code 10062547;Term: Congenital myopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Ventoline tablet 2mg INN or Proposed INN: SALBUTAMOL SULFATE Trade Name: Ventoline oral solution 0,4mg/ml INN or Proposed INN: SALBUTAMOL SULFATE | Västra götalandsregionen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Sweden |
218. Alport syndrome
Clinical trials : 30 / Drugs : 36 - (DrugBank : 15) / Drug target genes : 8 - Drug target pathways : 46
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 | NCT04937907 (ClinicalTrials.gov) | September 8, 2021 | 17/6/2021 | Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS) | Efficacy and Safety of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS) | Alport Syndrome, X-Linked | Drug: Hydroxychloroquine Sulfate 100 milligram (mg) Tab;Drug: Benazepril hydrochloride 10 milligram (mg) Tab | Shanghai Children's Hospital | NULL | Recruiting | 3 Years | 18 Years | All | 50 | Phase 2 | China |
222. Primary nephrotic syndrome
Clinical trials : 310 / Drugs : 295 - (DrugBank : 117) / Drug target genes : 63 - Drug target pathways : 194
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 | ChiCTR1900021757 | 2019-03-01 | 2019-03-08 | A randomized controlled trial for hydroxychloroquine sulfate in the treatment of idiopathic membranous nephropathy | The efficacy and safety of hydroxychloroquine sulfate in idiopathic membranous nephropathy: A randomized, controlled, Single-center clinical trial | Idiopathic Membranous Nephropathy | Group 1:Supportive treatment+Perindopril 8 mg/day;Group 2:Supportive treatment+Perindopril 8 mg/day+hydroxychloroquine sulfate (200mg 2/d);Group 3:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml);Group 4:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml)+hydroxychloroquine sulfate (200mg 2/d); | Nephrology Division, First Hospital Affiliated to Army Medical University | NULL | Recruiting | 18 | 60 | Both | Group 1:55;Group 2:55;Group 3:55;Group 4:55; | Phase 4 | China |
224. Purpura nephritis
Clinical trials : 16 / Drugs : 43 - (DrugBank : 21) / Drug target genes : 15 - Drug target pathways : 58
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 | ChiCTR2200057905 | 2022-04-01 | 2022-03-21 | A prospective, open, randomized controlled study of hydroxychloroquine sulfate in the treatment of adult Henoch Schonlein purpura nephritis | A prospective, open, randomized controlled study of hydroxychloroquine sulfate in the treatment of adult Henoch Schonlein purpura nephritis | Henoch Schonlein purpura nephritis | Experimental group:Hydroxychloroquine sulfate;Control group:Conventional therapy; | Daping Hospital, Army Medical University | NULL | Recruiting | 18 | Both | Experimental group:42;Control group:42; | Phase 4 | China |
226. Interstitial cystitis with Hunners ulcer
Clinical trials : 145 / Drugs : 156 - (DrugBank : 51) / Drug target genes : 64 - Drug target pathways : 146
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 | NCT03463499 (ClinicalTrials.gov) | September 22, 2017 | 25/2/2018 | The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients | The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients | Interstitial Cystitis | Drug: Hyaluronic Acid and Chondroitin Sulfate | Samsung Medical Center | NULL | Completed | 20 Years | N/A | All | 62 | N/A | Korea, Republic of |
2 | NCT01813565 (ClinicalTrials.gov) | March 20, 2013 | 11/3/2013 | The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome. | The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome. | Interstitial Cystitis | Drug: Hyaluronic acid/chondroitin sulfate | Asan Medical Center | NULL | Terminated | 20 Years | N/A | All | 15 | N/A | Korea, Republic of |
3 | EUCTR2010-021556-25-IT (EUCTR) | 24/02/2011 | 04/11/2010 | Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)AscoltaTrascrizione foneticaDizionario - Visualizza dizionario dettagliato - IBSA 01-2010 | Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)AscoltaTrascrizione foneticaDizionario - Visualizza dizionario dettagliato - IBSA 01-2010 | Interstitial Cystitis MedDRA version: 9.1;Level: HLGT;Classification code 10018188 | Trade Name: RIMSO 50 INN or Proposed INN: Dimethyl sulfoxide | IBSA | NULL | Not Recruiting | Female: yes Male: no | Phase 3 | Italy | |||
4 | NCT00919113 (ClinicalTrials.gov) | July 2009 | 11/6/2009 | Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome | A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome | Interstitial Cystitis;Painful Bladder Syndrome | Drug: 2% sodium chondroitin sulfate;Drug: Placebo | Watson Pharmaceuticals | NULL | Completed | 18 Years | N/A | Female | 98 | Phase 2 | United States |
265. Lipodystrophy
Clinical trials : 112 / Drugs : 155 - (DrugBank : 55) / Drug target genes : 25 - Drug target pathways : 97
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 | NCT00028314 (ClinicalTrials.gov) | March 2002 | 20/12/2001 | Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients | A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting | HIV Infections;Lipodystrophy;Wasting Disease | Drug: Abacavir sulfate;Drug: Atazanavir/Ritonavir;Drug: Lopinavir/Ritonavir;Drug: Nevirapine | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 13 Years | N/A | Both | 150 | N/A | United States |
2 | NCT00021463 (ClinicalTrials.gov) | April 2001 | 14/7/2001 | Changing to Nonprotease Inhibitor Treatment to Improve Side Effects | Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities | HIV Infections;Lipodystrophy | Drug: Abacavir sulfate, Lamivudine and Zidovudine;Drug: Abacavir sulfate;Drug: Efavirenz;Drug: Nevirapine | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 13 Years | N/A | Both | 342 | Phase 2 | United States |
3 | NCT00005764 (ClinicalTrials.gov) | May 2000 | 30/5/2000 | A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients | Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL) | HIV Infections;Lipodystrophy | Drug: Lamivudine/Zidovudine;Drug: Abacavir sulfate;Drug: Lamivudine | Glaxo Wellcome | NULL | Completed | 18 Years | N/A | Both | 100 | Phase 4 | United States |
296. Biliary atresia
Clinical trials : 71 / Drugs : 70 - (DrugBank : 39) / Drug target genes : 35 - Drug target pathways : 60
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 | NCT00007033 (ClinicalTrials.gov) | October 2000 | 6/12/2000 | Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease | Alagille Syndrome;Cholestasis;Biliary Atresia | Drug: magnesium gluconate;Drug: magnesium sulfate | National Center for Research Resources (NCRR) | Children's Hospital Medical Center, Cincinnati | Completed | 3 Years | 18 Years | Both | 25 | N/A | United States |
297. Alagille syndrome
Clinical trials : 45 / Drugs : 21 - (DrugBank : 10) / Drug target genes : 3 - Drug target pathways : 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 | NCT00007033 (ClinicalTrials.gov) | October 2000 | 6/12/2000 | Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease | Alagille Syndrome;Cholestasis;Biliary Atresia | Drug: magnesium gluconate;Drug: magnesium sulfate | National Center for Research Resources (NCRR) | Children's Hospital Medical Center, Cincinnati | Completed | 3 Years | 18 Years | Both | 25 | N/A | United States |
299. Cystic fibrosis
Clinical trials : 1,695 / Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 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 | EUCTR2016-001785-29-IE (EUCTR) | 15/08/2016 | 10/05/2016 | Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF. | Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kalydeco INN or Proposed INN: IVACAFTOR Trade Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Flucloxicillin INN or Proposed INN: FLUCLOXACILLIN SODIUM Trade Name: Fortum INN or Proposed INN: CEFTAZIDIME Product Name: Tobramycin INN or Proposed INN: TOBRAMYCIN SULFATE Trade Name: Meropenem INN or Proposed INN: Meropenem Other descriptive name: MEROPENEM Trade Name: Colistin INN or Proposed INN: COLISTIMETHATE SODIUM | St. Vincent's University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Ireland | |||
2 | EUCTR2013-004295-35-AT (EUCTR) | 30/04/2014 | 02/04/2014 | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT | Chronic lung P. Aeruginosa Infection MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler INN or Proposed INN: aztreonam Other descriptive name: AZTREONAM LYSINE Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: TOBI Product Name: Tobi INN or Proposed INN: TOBRAMYCIN SULFATE | Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III) | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | Austria | ||
3 | EUCTR2011-000443-24-NL (EUCTR) | 25/04/2013 | 06/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
4 | EUCTR2011-000443-24-DK (EUCTR) | 14/12/2012 | 22/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
5 | EUCTR2011-000441-20-NL (EUCTR) | 11/09/2012 | 06/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom | |||
6 | EUCTR2011-000441-20-BG (EUCTR) | 13/06/2012 | 03/05/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
7 | EUCTR2011-000443-24-SE (EUCTR) | 24/05/2012 | 07/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
8 | EUCTR2011-000441-20-IE (EUCTR) | 02/05/2012 | 26/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Code: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
9 | EUCTR2011-000443-24-IT (EUCTR) | 10/04/2012 | 19/03/2012 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin Product Code: NA INN or Proposed INN: AMIKACIN SULFATE | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 250 | Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
10 | EUCTR2011-000441-20-DK (EUCTR) | 29/03/2012 | 22/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
11 | EUCTR2011-000441-20-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI Product Code: N/A INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany | ||
12 | EUCTR2011-000443-24-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
13 | EUCTR2011-000443-24-PL (EUCTR) | 20/01/2012 | 06/10/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
14 | EUCTR2011-000443-24-DE (EUCTR) | 11/10/2011 | 30/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
15 | EUCTR2011-000442-38-BG (EUCTR) | 03/10/2011 | 05/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
16 | EUCTR2011-000443-24-BG (EUCTR) | 03/10/2011 | 28/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
17 | EUCTR2011-000441-20-IT (EUCTR) | 01/10/2011 | 08/03/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE Trade Name: Tobi INN or Proposed INN: TOBRAMYCIN | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy | |||
18 | EUCTR2011-000442-38-ES (EUCTR) | 21/09/2011 | 11/11/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
19 | EUCTR2011-000441-20-DE (EUCTR) | 19/09/2011 | 30/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
20 | EUCTR2011-000443-24-GR (EUCTR) | 09/08/2011 | 23/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
21 | EUCTR2011-000443-24-IE (EUCTR) | 05/08/2011 | 26/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
22 | EUCTR2011-000443-24-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
23 | EUCTR2011-000441-20-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
24 | EUCTR2011-000443-24-FR (EUCTR) | 28/07/2011 | 31/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
25 | EUCTR2011-000443-24-AT (EUCTR) | 22/07/2011 | 27/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
26 | EUCTR2011-000441-20-AT (EUCTR) | 19/07/2011 | 21/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
27 | EUCTR2011-000441-20-GR (EUCTR) | 15/07/2011 | 22/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
28 | EUCTR2011-000443-24-SK (EUCTR) | 04/07/2011 | 20/02/2014 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands | ||
29 | EUCTR2011-000441-20-SK (EUCTR) | 04/07/2011 | 25/11/2014 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
30 | EUCTR2011-000443-24-HU (EUCTR) | 29/06/2011 | 11/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
31 | EUCTR2011-000441-20-HU (EUCTR) | 29/06/2011 | 20/04/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
32 | NCT01755455 (ClinicalTrials.gov) | June 2011 | 19/12/2012 | Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis | Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis | Cystic Fibrosis;Anemia, Iron-Deficiency | Drug: Ferrous sulfate 325mg;Drug: Placebo | Dartmouth-Hitchcock Medical Center | NULL | Completed | 18 Years | 70 Years | All | 22 | N/A | United States |
33 | EUCTR2006-006980-22-BE (EUCTR) | 27/06/2007 | 19/07/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin sulfate | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Belgium | |||
34 | EUCTR2011-000442-38-PL (EUCTR) | 01/08/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
35 | EUCTR2006-006980-22-PL (EUCTR) | 22/08/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Slovakia;Belgium;Poland |