DOSTINEX ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 75 | クッシング病 | 10 |
75. クッシング病
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 | 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 | ||
| 5 | 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 | ||
| 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-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 | ||
| 8 | 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 | ||
| 9 | 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 | ||||
| 10 | 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 |