75. クッシング病 Cushing disease Clinical trials / Disease details
臨床試験数 : 205 / 薬物数 : 176 - (DrugBank : 45) / 標的遺伝子数 : 61 - 標的パスウェイ数 : 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 | 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 | ||
| 2 | NCT02060383 (ClinicalTrials.gov) | May 23, 2014 | 10/2/2014 | Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly | A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly | Cushing's Disease;Acromegaly | Drug: Pasireotide s.c.;Drug: Sitagliptin;Drug: Liraglutide;Drug: Insulin;Drug: Pasireotide LAR;Drug: Metformin | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 249 | Phase 4 | United States;Belgium;Brazil;China;Denmark;Germany;India;Peru;Poland;Russian Federation;Thailand;Turkey |
| 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-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 | ||
| 7 | 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 | ||
| 8 | NCT02310269 (ClinicalTrials.gov) | March 28, 2013 | 26/9/2014 | Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease | Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study) | Cushings Disease | Drug: SOM230 | RECORDATI GROUP | NULL | Recruiting | 18 Years | N/A | All | 200 | United States;Canada;Colombia;France;Germany;Israel;Italy;Lebanon;Netherlands;Romania;Sweden;United Kingdom;Denmark | |
| 9 | EUCTR2010-024165-44-NL (EUCTR) | 24/04/2012 | 22/12/2011 | Study of pasireotide s.c. in patients with Cushing's disease | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease 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] | Product Code: SOM230 INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Egypt;Hungary;Czech Republic;Greece;Argentina;Thailand;Spain;Brazil;Romania;Germany;Netherlands;Korea, Republic of | ||
| 10 | EUCTR2010-024165-44-CZ (EUCTR) | 02/09/2011 | 18/07/2011 | safety and efficacy of pasireotide s.c. in patients with Cushing's disease | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE INN or Proposed INN: PASIREOTIDE DIASPARTATE INN or Proposed INN: PASIREOTIDE DIASPARTATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Czech Republic;Greece;Brazil;Thailand;Spain;Romania;Russian Federation;Netherlands;Germany;Korea, Republic of | |||
| 11 | NCT01582061 (ClinicalTrials.gov) | August 16, 2011 | 12/4/2012 | An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. | An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape). | Cushing's Disease | Drug: Pasireotide sub-cutaneous | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 104 | Phase 3 | United States;Brazil;Czechia;Germany;Greece;Korea, Republic of;Lebanon;Romania;Russian Federation;Spain;Thailand;Czech Republic;Egypt;Netherlands |
| 12 | EUCTR2010-024165-44-GR (EUCTR) | 09/08/2011 | 22/06/2011 | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders | Product Name: N/A Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: - INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Czech Republic;Greece;Spain;Netherlands;Germany | |||
| 13 | EUCTR2010-024165-44-DE (EUCTR) | 05/08/2011 | 12/05/2011 | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Name: Signifor Product Code: SOM230 300µg INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: Signifor Product Code: SOM230 600µg INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: Signifor Product Code: SOM230 900µg INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Czech Republic;Greece;Spain;Netherlands;Germany |