75. クッシング病 Cushing disease Clinical trials / Disease details
臨床試験数 : 203 / 薬物数 : 191 - (DrugBank : 51) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 128
| 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 | EUCTR2019-004019-29-IT (EUCTR) | 15/07/2021 | 07/10/2020 | Italian study to evaluate the efficacy of retinoic acid and cabergoline therapy in combination in Cushing's disease. | Medical combination therapy with retinoic acid and cabergoline in ACTH-secreting pituitary adenoma: a prospective and randomized study. - CRACCA | Cushing's disease in patients in whom pituitary surgery has not been curative or in situations where it is contraindicated or refused by patient. MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Dostinex Product Name: Cabergolina Product Code: [G02CB03] INN or Proposed INN: CABERGOLINA Other descriptive name: NON COMMERCIAL Trade Name: VESANOID Product Name: Tretinoina Product Code: [L01XX14] INN or Proposed INN: TRETINOINA Other descriptive name: NON COMMERCIAL | Dipartimento di Medicina-DIMED, università di Padova | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Italy | ||
| 2 | EUCTR2013-002170-49-NL (EUCTR) | 25/03/2015 | 17/12/2014 | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | Cushing's disease MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Dostinex Product Name: Cabergoline INN or Proposed INN: cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands | ||
| 3 | EUCTR2013-002170-49-BE (EUCTR) | 19/03/2014 | 04/12/2013 | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | Cushing's disease MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 | Trade Name: Signifor Product Name: pasireotide 0.3mg Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide 0.6mg Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide 0.9 mg Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Dostinex Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 4 | NCT01915303 (ClinicalTrials.gov) | March 6, 2014 | 10/6/2013 | Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease | A Phase II Trial to Assess the Efficacy and Safety of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's Disease | Cushings Disease | Drug: Pasireotide with or without cabergoline | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 68 | Phase 2 | United States;Argentina;Belgium;Brazil;Colombia;France;Germany;Greece;Hungary;India;Italy;Malaysia;Mexico;Netherlands;Spain;Turkey;Australia;Bulgaria;Venezuela |
| 5 | EUCTR2013-002170-49-HU (EUCTR) | 03/02/2014 | 13/12/2013 | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | Cushing's disease MedDRA version: 18.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Dostinex Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 6 | EUCTR2013-002170-49-GR (EUCTR) | 29/01/2014 | 24/01/2014 | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease | Cushing's disease | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Dostinex Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany | ||
| 7 | EUCTR2013-002170-49-IT (EUCTR) | 21/01/2014 | 22/10/2013 | Study of the efficacy and safety of pasireotide s.c. +/- cabergoline in patients with Cushing’s disease | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease | Cushing's disease MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: NA Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: NA Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: NA Trade Name: Dostinex Product Name: Cabergoline Product Code: NA INN or Proposed INN: cabergoline Other descriptive name: NA | NOVARTIS FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany | ||
| 8 | EUCTR2013-002170-49-FR (EUCTR) | 27/12/2013 | 03/12/2015 | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease | Cushing's disease | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: CABERGOLINE TEVA Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 9 | EUCTR2013-002170-49-ES (EUCTR) | 21/11/2013 | 12/11/2013 | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s disease | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: SIGNIFOR Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: SIGNIFOR Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: SIGNIFOR Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: Dostinex Product Name: Cabergoline INN or Proposed INN: CABERGOLINE Other descriptive name: CABERGOLINE | Novartis Farmacéutica , S.A. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 10 | EUCTR2013-002170-49-DE (EUCTR) | 19/11/2013 | 17/09/2013 | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease | Cushing's disease MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Dostinex Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany | ||
| 11 | NCT01794793 (ClinicalTrials.gov) | June 10, 2013 | 15/2/2013 | Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies | An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment | Cushing's Disease;Acromegaly;Neuroendocrine Tumors;Pituitary Tumors;Ectopic ACTH Secreting (EAS) Tumors;Dumping Syndrome;Prostate Cancer;Melanoma Negative for bRAF;Melanoma Negative for nRAS | Drug: Pasireotide;Drug: Cabergoline | RECORDATI GROUP | NULL | Active, not recruiting | 18 Years | N/A | All | 413 | Phase 4 | United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Taiwan;Thailand;Turkey;China |
| 12 | EUCTR2011-003264-77-NL (EUCTR) | 31/10/2011 | 07/09/2011 | A study with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease. | A prospective trial with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease. - Octreotide and ketoconazole for Cushing's disease | Cushing's disease (which is caused by an ACTH producing pituitary adenoma) MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Octreotide Product Name: Octreotide Product Code: RVG 18236 Trade Name: Ketoconazole Product Name: Ketoconazole Product Code: RVG 08938 Trade Name: Cabergoline Product Name: Cabergoline Product Code: RVG 15375 | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 13 | EUCTR2010-018720-12-SE (EUCTR) | 22/04/2010 | 18/02/2010 | Behandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom(treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergoline | Behandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom(treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergoline | A) Men and women aged 18 to 75 years with hypercortisolism due to ACTH-dependent Cushing's syndrome will be treated in the period between diagnosis and planned surgery or radiation therapy.B) Men and women aged 18 to 75 years due to ACTH-dependent Cushing's syndrome who have persistent hypercortisolism post-surgery or post-radiotherapy. | Product Name: cabergoline | Swedish Pituitary Study group | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Sweden | |||
| 14 | NCT00889525 (ClinicalTrials.gov) | November 2007 | 27/4/2009 | Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor | Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor | Cushing's Disease;Corticotroph Adenoma | Drug: Cabergoline | Seth Gordhandas Sunderdas Medical College | NULL | Completed | 12 Years | N/A | Both | Phase 3 | India | |
| 15 | EUCTR2006-004080-55-NL (EUCTR) | 26/04/2007 | 19/01/2007 | Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease | Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease | The medical condition to be investigated is Cushing's disease which is caused by an ACTH producing pituitary adenoma MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease | Product Name: SOM230 Product Code: SOM230B INN or Proposed INN: pasireotide Trade Name: Dostinex Product Name: Dostinex INN or Proposed INN: CABERGOLINE Trade Name: Nizoral Product Name: Ketoconazole INN or Proposed INN: KETOCONAZOLE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 16 | EUCTR2006-005218-11-IT (EUCTR) | 15/09/2006 | 03/04/2007 | EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME | EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME | Cushing syndrome MedDRA version: 9.1;Level: LLT;Classification code 10011652;Term: Cushing's syndrome | Trade Name: DOSTINEX Trade Name: NIZORAL | ASSOCIAZIONE ITALIANA ENDOCRINOLOGIA-METABOLISMO-IPOFISI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy |