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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004019-29-IT
(EUCTR)
15/07/202107/10/2020Italian 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 PadovaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Italy
2EUCTR2013-002170-49-NL
(EUCTR)
25/03/201517/12/2014A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s diseaseA 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 AGNULLNot 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): noUnited States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands
3EUCTR2013-002170-49-BE
(EUCTR)
19/03/201404/12/2013 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 AGNULLNot 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): noUnited States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
4EUCTR2013-002170-49-HU
(EUCTR)
03/02/201413/12/2013A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
5EUCTR2013-002170-49-GR
(EUCTR)
29/01/201424/01/2014A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s diseaseA 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 diseaseProduct 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 AGNULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany
6EUCTR2013-002170-49-IT
(EUCTR)
21/01/201422/10/2013Study of the efficacy and safety of pasireotide s.c. +/- cabergoline in patients with Cushing’s diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany
7EUCTR2013-002170-49-ES
(EUCTR)
21/11/201312/11/2013A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
8EUCTR2013-002170-49-DE
(EUCTR)
19/11/201317/09/2013A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany
9EUCTR2006-004080-55-NL
(EUCTR)
26/04/200719/01/2007Stepwise 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 DiseaseStepwise 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
10EUCTR2006-005218-11-IT
(EUCTR)
15/09/200603/04/2007EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROMEEFFECTIVENESS 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-IPOFISINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy