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 75. クッシング病 [臨床試験数:77,薬物数:106(DrugBank:41),標的遺伝子数:33,標的パスウェイ数:105] 

Searched query = "Cushing disease", "Cushing"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03708900October 31, 20194 November 2019Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's DiseaseA Phase II, Multicenter, Open-label, Non-comparative Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Osilodrostat in Children and Adolescent Patients With Cushing's DiseaseCushing's DiseaseDrug: LCI699Novartis PharmaceuticalsRecruiting6 Years18 YearsAll12Phase 2Bulgaria;United Kingdom
2NCT03974789July 1, 201926 August 2019Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of HypercorticismsDiscriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation StudyCushing DiseaseDiagnostic Test: Blood test;Diagnostic Test: 24-hour Urine test;Diagnostic Test: Saliva swab;Diagnostic Test: Dexamethasone testCentre Hospitalier Universitaire de NimesRecruiting18 Years65 YearsAll380Phase 1France
3EUCTR2017-004647-20-ES17/01/201928 February 2019A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s SyndromeEndogenous Cushing´s syndrome (CS)
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: levoketoconazole
Product Code: COR-003
Pharmaceutical Form: Tablet
INN or Proposed INN: levoketozonazole
CAS Number: 142128-57-2
Current Sponsor code: COR-003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Cortendo ABAuthorised Female: yes
Male: yes
60Phase 3United States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands
4NCT03621280January 7, 201922 October 2019Open-label Treatment in Cushing's SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's SyndromeCushing Syndrome;Cushing DiseaseDrug: LevoketoconazoleCortendo ABRecruiting18 YearsN/AAll60Phase 3United States;Bulgaria;France;Greece;Hungary;Israel;Italy;Netherlands;Poland;Romania;Spain;Denmark;Turkey
5EUCTR2017-004647-20-HU13/11/201819 November 2018A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s SyndromeEndogenous Cushing´s syndrome (CS)
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: levoketoconazole
Product Code: COR-003
Pharmaceutical Form: Tablet
INN or Proposed INN: levoketozonazole
CAS Number: 142128-57-2
Current Sponsor code: COR-003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Cortendo ABAuthorisedFemale: yes
Male: yes
60Phase 3Hungary;Poland;Romania;United States;Greece;Spain;Turkey;Israel;Italy;France;Denmark;Bulgaria;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03774446November 2, 201818 December 2018Multicenter Study of Seliciclib (R-roscovitine) for Cushing DiseaseA Phase 2 Multicenter Study of Seliciclib (R-roscovitine) for Cushing DiseaseCushing DiseaseDrug: SeliciclibCedars-Sinai Medical CenterRecruiting18 YearsN/AAll29Phase 2United States
7EUCTR2017-002840-34-ES31/10/20187 January 2019Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostatCushing's syndrome
MedDRA version: 20.0 Level: PT Classification code 10011652 Term: Cushing's syndrome System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: osilodrostat 5mg
Product Code: LCI699
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: osilodrostat 10mg
Product Code: LCI699
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Novartis Farmacéutica, S.AAuthorisedFemale: yes
Male: yes
200Phase 2United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
8NCT03697109October 16, 201830 September 2019A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing SyndromeGlucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of RelacorilantCushing SyndromeDrug: Relacorilant;Other: PlaceboCorcept TherapeuticsRecruiting18 Years80 YearsAll130Phase 3United States;Bulgaria;Israel;Italy;Netherlands;Poland;Spain
9EUCTR2017-002840-34-AT03/08/201810 September 2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostatCushing's syndrome
MedDRA version: 20.0 Level: PT Classification code 10011652 Term: Cushing's syndrome System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: osilodrostat 5mg
Product Code: LCI699
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: osilodrostat 10mg
Product Code: LCI699
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
200Phase 2United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
10EUCTR2018-001616-30-HU09/07/201823 July 2018Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing SyndromeEndogenous Cushing Syndrome
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Relacorilant
CAS Number: 1496510-51-0
Current Sponsor code: CORT125134
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Corcept Therapeutics IncorporatedAuthorisedFemale: yes
Male: yes
75Phase 2United States;Hungary;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-001219-35-NL24/05/201828 February 2019A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s SyndromeEndogenous Cushing´s syndrome (CS)
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
Pharmaceutical Form: Tablet
INN or Proposed INN: levoketozonazole
CAS Number: 142128-57-2
Current Sponsor code: COR-003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Cortendo ABAuthorised Female: yes
Male: yes
54Phase 3France;United States;Hungary;Greece;Poland;Spain;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
12JPRN-jRCTs02118003924/05/201810 September 2019The usefulness of DDAVP test and GHRP-2 test in patients with Cushing's diseaseThe usefulness of DDAVP test and GHRP-2 test in patients with Cushing's disease - Cushing_diagnosisCushing's diseaseadministration of DDAVP or GHRP-2Kazunori KageyamaRecruiting15ageNot applicatedBoth15Phase 3none
13NCT03604198May 7, 201820 August 2018Extension Study to Evaluate the Safety and Clinical Benefit of Long-Term Use of Relacorilant in Patients With Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing SyndromeCushing SyndromeDrug: relacorilantCorcept TherapeuticsRecruitingN/AN/AAll75Phase 2United States
14EUCTR2017-001219-35-BG23/01/201830 April 2019A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s SyndromeEndogenous Cushing´s syndrome (CS)
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
Pharmaceutical Form: Tablet
INN or Proposed INN: levoketozonazole
CAS Number: 142128-57-2
Current Sponsor code: COR-003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Cortendo ABAuthorised Female: yes
Male: yes
54Phase 3France;United States;Hungary;Greece;Poland;Spain;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
15EUCTR2017-001219-35-ES22/01/201829 January 2018A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s SyndromeEndogenous Cushing´s syndrome (CS)
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
Pharmaceutical Form: Tablet
INN or Proposed INN: levoketozonazole
CAS Number: 142128-57-2
Current Sponsor code: COR-003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Cortendo ABAuthorisedFemale: yes
Male: yes
40Phase 3United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-001219-35-PL16/01/201828 February 2019A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s SyndromeEndogenous Cushing´s syndrome (CS)
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
Pharmaceutical Form: Tablet
INN or Proposed INN: levoketozonazole
CAS Number: 142128-57-2
Current Sponsor code: COR-003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Cortendo ABAuthorised Female: yes
Male: yes
35Phase 3France;United States;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
17EUCTR2017-001219-35-HU12/01/201822 January 2018A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s SyndromeEndogenous Cushing´s syndrome (CS)
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
Pharmaceutical Form: Tablet
INN or Proposed INN: levoketozonazole
CAS Number: 142128-57-2
Current Sponsor code: COR-003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Cortendo ABAuthorisedFemale: yes
Male: yes
35Phase 3France;United States;Hungary;Greece;Poland;Spain;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
18NCT03346954December 1, 201716 December 2017Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's DiseaseImpact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's DiseaseCushing's DiseaseOther: [11C]-Methionine PET/MRIHospices Civils de LyonNot recruiting18 YearsN/AAll30N/AFrance
19NCT03277690September 26, 201722 July 2019A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's SyndromeEndogenous Cushing's SyndromeDrug: Levoketoconazole;Drug: PlaceboCortendo ABRecruiting18 YearsN/AAll54Phase 3United States;Spain;Romania;Poland;Netherlands;Italy;Israel;Hungary;Greece;France;Denmark;Bulgaria
20ChiCTR-OPC-170116642017-08-0119 June 2017A single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's diseaseA single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's diseasePituitary ACTH-secreting adenomaTreatment group:lapatinib;Peking Union Medical College HospitalNot Recruiting1875BothTreatment group:30;Post-marketChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03111810May 25, 201716 December 2017Targeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 InhibitionTargeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI)Iatrogenic Cushing's DiseaseDrug: AZD4017 and prednisolone;Drug: Placebo Oral Tablet and prednisoloneUniversity of OxfordAstraZenecaRecruiting18 Years60 YearsMale32Phase 2United Kingdom
22NCT03145285April 18, 201716 December 2017Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical CarcinomaActivity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical CarcinomaCushing Syndrome;Adrenocortical CarcinomaDrug: Abiraterone AcetateAzienda Ospedaliera Spedali Civili di BresciaFondazione IRCCS Istituto Nazionale dei Tumori, Milano;Niguarda Hospital;San Camillo Hospital, Rome;San Luigi Gonzaga HospitalNot recruiting18 YearsN/AAll10Phase 2Italy
23NCT03053271April 13, 201730 September 2019A Study of ATR-101 for the Treatment of Endogenous Cushing's SyndromeA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing's SyndromeCushing SyndromeDrug: ATR-101;Drug: PlaceboMillendo Therapeutics US, Inc.Not recruiting18 Years80 YearsAll4Phase 2United States;United Kingdom
24EUCTR2016-003060-40-GB17/01/20178 May 2017Treating side effects of steroid medicationTargeting Iatrogenic Cushing’s Syndrome with 11ß-hydroxysteroid dehydrogenase type 1 Inhibition - TICSI version 0.6Adverse effects of prescribed glucocorticoid therapy
MedDRA version: 19.0 Level: LLT Classification code 10068501 Term: Cushing's syndrome, steroid-induced System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: AZD4017
Product Code: AZD4017
Pharmaceutical Form: Tablet
INN or Proposed INN: no INN available
CAS Number: 1024033-43-9
Current Sponsor code: TICSI
Other descriptive name: AZD4017
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
University of Oxford, Clinical Trials and Research GovernanceAuthorisedFemale: no
Male: yes
32Phase 2United Kingdom
25NCT02697734October 3, 201630 September 2019Efficacy and Safety Evaluation of Osilodrostat in Cushing's DiseaseA Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's DiseaseCushing's DiseaseDrug: osilodrostat;Drug: osilodrostat PlaceboNovartis PharmaceuticalsNot recruiting18 Years75 YearsAll73Phase 3United States;Belgium;Brazil;Canada;China;Costa Rica;Greece;Poland;Portugal;Russian Federation;Spain;Switzerland;Thailand;Turkey
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2016-000899-23-GB16/08/201628 February 2019Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndromePhase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s SyndromeEndogenous Cushing’s Syndrome
MedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Relacorilant
CAS Number: 1496510-51-0
Current Sponsor code: CORT125134
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Corcept Therapeutics IncorporatedNot Recruiting Female: yes
Male: yes
30Phase 2United States;Hungary;Netherlands;United Kingdom
27NCT02611258July 20165 February 2018Endocrine Cardiomyopathy in Cushing Syndrome: Response to Cyclic GMP PDE5 inhibitOrsStudy on New Insights in Remodeling of Endocrine Cardiomyopathies: Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in Cushing's SyndromeCushing's Syndrome CardiomyopathyDrug: TadalafilAndrea M. IsidoriRecruiting18 Years75 YearsAll18Phase 2Italy
28NCT02804750June 201622 October 2019Study to Evaluate CORT125134 in Participants With Cushing's SyndromePhase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's SyndromeCushing's SyndromeDrug: CORT125134Corcept TherapeuticsNot recruiting18 Years80 YearsAll35Phase 2United States;Hungary;Italy;Netherlands;United Kingdom
29EUCTR2014-004092-23-ES29/04/201613 June 2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing?s disease - LINC-4Cushing'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]
Product Name: osilodrostat 1mg
Product Code: LCI699
Pharmaceutical Form: Tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: osilodrostat 5mg
Product Code: LCI699
Pharmaceutical Form: Tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: osilodrostat 10mg
Product Code: LCI699
Pharmaceutical Form: Tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: osilodrostat 20mg
Product Code: LCI699
Pharmaceutical Form: Tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Novartis Farmacéutica, S.A.AuthorisedFemale: yes
Male: yes
69Phase 3United States;Greece;Poland;Brazil;Belgium;Thailand;Spain;Turkey;Denmark;Russian Federation;Switzerland
30JPRN-UMIN0000188912015/10/012 April 2019The usefulness of DDAVP test and GHRP-2 test in patients with Cushing's diseaseCushing's diseaseadministration of DDAVP or GHRP-2Department of Endocrinology and Metabolism, Hirosaki University Graduate School of MedicineRecruiting15years-oldNot applicableMale and Female15Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT02468193September 24, 20159 September 2019Study of Efficacy and Safety of Osilodrostat in Cushing's SyndromeA Phase II, Open-label, Dose Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of Osilodrostat in Patients With All Types of Endogenous Cushing's Syndrome Except Cushing's DiseaseCushing's Syndrome;Ectopic Corticotropin Syndrome;Adrenal Adenoma;Adrenal Carcinoma;AIMAH;PPNADDrug: OsilodrostatNovartis PharmaceuticalsNot recruiting18 Years85 YearsAll9Phase 2Japan
32NCT02484755June 20153 August 2015Targeted Therapy With Gefitinib in Patients With USP8-mutated Cushing's DiseaseTargeted Therapy With Gefitinib in Patients With USP8-mutated Cushing's DiseaseCushing's Disease;Corticotrophin AdenomaDrug: GefitinibHuashan HospitalRecruiting18 Years70 YearsBoth6Phase 2China
33NCT02297945April 201528 October 2019Effects of Metyrapone in Patients With Endogenous Cushing's SyndromeProspective, Single Arm, Open-label, Multicenter, International Study to Assess the Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome During a 12-week Treatment Period Followed by an Extension Period of 24 WeeksCushing's SyndromeDrug: metyraponeHRA PharmaNot recruiting18 YearsN/AAll50Phase 3Belgium;Germany;Hungary;Italy;Poland;Romania;Spain;Turkey
34EUCTR2014-000162-22-IT19/03/201517 August 2015Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment periodProspective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPTTreatment of Cushing’s syndrome
MedDRA version: 17.1 Level: PT Classification code 10011652 Term: Cushing's syndrome System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Metopirone 250 mg capsules/Cormeto
Product Name: metyrapone
Pharmaceutical Form: Capsule
INN or Proposed INN: METYRAPONE
CAS Number: 54-36-4
Concentration unit: mg milligram(s)
Concentration number: 250-
Laboratoire HRA PharmaAuthorisedFemale: yes
Male: yes
70United States;Poland;Belgium;Spain;Germany;Switzerland;Italy;Sweden
35NCT02180217October 6, 201428 October 2019Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's DiseasePhase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's DiseaseCushing's DiseaseDrug: LCI699;Drug: LCI699 matching placeboNovartis PharmaceuticalsNot recruiting18 Years75 YearsAll137Phase 3United States;Argentina;Austria;Bulgaria;Canada;China;Colombia;France;Germany;India;Italy;Japan;Korea, Republic of;Netherlands;Russian Federation;Spain;Thailand;Turkey;United Kingdom;Australia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2012-002916-16-DE19/08/201428 February 2019Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegalyA 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 and acromegaly
MedDRA version: 19.0 Level: LLT Classification code 10011651 Term: Cushing's disease System Organ Class: 100000004860
MedDRA version: 19.0 Level: LLT Classification code 10000600 Term: Acromegaly and gigantism System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 300micrograms
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE DIASPARTATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 300-
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 600 micrograms
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE DIASPARTATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 600-
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 900 micrograms
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE DIASPARTATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 900-
Product Name: pasireotide LAR
Product Code: SOM230 LAR, 20 mg
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: PASIREOTIDE
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE PAMOATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Novartis Pharma Services AGNot Recruiting Female: yes
Male: yes
133Phase 4United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
37EUCTR2013-004766-34-IT01/08/20149 March 2015Safety and efficacy of LCI699 for the treatment of patients with Cushing's diseaseA Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s diseaseCushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Product Name: NA
Product Code: LCI699
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 1315449-72-9
Current Sponsor code: LCI699
Other descriptive name: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: NA
Product Code: LCI699
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 1315449-72-9
Current Sponsor code: LCI699
Other descriptive name: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: NA
Product Code: LCI699
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 1315449-72-9
Current Sponsor code: LCI699
Other descriptive name: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: NA
Product Code: LCI699
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 1315449-72-9
Current Sponsor code: LCI699
Other descriptive name: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
NOVARTIS FARMA S.p.A.AuthorisedFemale: yes
Male: yes
132Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of
38NCT01838551August 201418 December 2018Treatment for Endogenous Cushing's SyndromeAn Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's SyndromeEndogenous Cushing's SyndromeDrug: COR-003Cortendo ABNot recruiting18 YearsN/AAll90Phase 3United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Serbia;Spain;Turkey;Czech Republic;Georgia;Hungary;Sweden;Switzerland;United Kingdom
39NCT02060383May 23, 201421 January 2019Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or AcromegalyA 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 AcromegalyCushing's Disease;AcromegalyDrug: Pasireotide s.c.;Drug: Sitagliptin;Drug: Liraglutide;Drug: Insulin;Drug: Pasireotide LAR;Drug: MetforminNovartis PharmaceuticalsNot recruiting18 YearsN/AAll247Phase 4United States;Belgium;Brazil;China;Denmark;Germany;India;Peru;Poland;Russian Federation;Thailand;Turkey
40NCT02160730May 201419 November 2018Treatment of Cushing's Disease With R-roscovitineTreatment of Pituitary Cushing Disease With a Selective CDK Inhibitor, R-roscovitineCushings DiseaseDrug: R-roscovitineShlomo Melmed, MDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting18 YearsN/AAll7Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01915303March 6, 201424 June 2019Study 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 of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's DiseaseCushing's DiseaseDrug: Pasireotide with or without cabergolineNovartis PharmaceuticalsNot recruiting18 YearsN/AAll64Phase 2United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Colombia;France;Germany;Greece;Hungary;India;Italy;Malaysia;Mexico;Netherlands;Spain;Turkey;Venezuela
42NCT02019706November 26, 201328 October 2019Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing SyndromeEvaluation of 68Ga -DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing SyndromeACTH;Cushing's SyndromeDrug: DOTATATE PET-CT;Drug: F-DOPA PET CT;Drug: OCTREOTIDE;Radiation: CT Scan;Device: MRIEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Recruiting18 Years90 YearsAll80Phase 1/Phase 2United States
43EUCTR2013-002170-49-DE19/11/201330 April 2019A 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 diseaseCushing'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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE DIASPARTATE
CAS Number: 396091-77-3
Current Sponsor code: SOM230
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.3-
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE DIASPARTATE
CAS Number: 396091-77-3
Current Sponsor code: SOM230
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE DIASPARTATE
CAS Number: 396091-77-3
Current Sponsor code: SOM230
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.9-
Trade Name: Dostinex
Product Name: Cabergoline
Pharmaceutical Form: Tablet
Other descriptive name: CABERGOLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,5-
Novartis Pharma Services AGNot Recruiting Female: 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
44EUCTR2013-002063-26-IT08/09/20137 April 2015A trial with Metyrapone in Cushing's syndromeA prospective open-label Phase 2 study of METYRAPONE as a preoperative treatment in patients with ACTH-independent Cushing’s syndrome due to adrenal adenoma. - METYX01Cushing's syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Matyrapone
Product Name: Metyrapone
Product Code: Metyrapone
Pharmaceutical Form: Capsule, soft
S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi OrbassanoAuthorisedFemale: yes
Male: yes
15Phase 2Italy
45NCT01925092August 201319 February 2015Mifepristone in Children With Refractory Cushing's DiseaseAn Open-label Study of the Safety, Pharmacokinetics and Pharmacodynamics of Mifepristone in Children With Refractory Cushing's DiseaseCushing's DiseaseDrug: mifepristoneCorcept TherapeuticsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting6 Years17 YearsBoth0Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
46NCT01794793June 10, 20137 October 2019Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored StudiesAn 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 TreatmentCushing's Disease;Acromegaly;Neuroendocrine Tumors;Pituitary Tumors;Ectopic ACTH Secreting (EAS) Tumors;Dumping Syndrome;Prostate Cancer;Melanoma Negative for bRAF;Melanoma Negative for nRASDrug: Pasireotide;Drug: CabergolineNovartis PharmaceuticalsRecruiting18 YearsN/AAll500Phase 4United States;Argentina;Belgium;Brazil;Bulgaria;Canada;China;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
47NCT03080181May 201316 December 2017Adipokine Profile in Patients With Cushing's Disease on Pasireotide TreatmentAdipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion ParametersCushing DiseaseDrug: Pasireotide 0.6 MG/MLUniversity of PalermoNot recruiting18 YearsN/AAll24Phase 4
48NCT02310269March 28, 201329 July 2019Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's DiseaseNon-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 DiseaseDrug: SOM230Novartis PharmaceuticalsRecruiting18 YearsN/AAll200Phase 4United States;Canada;Colombia;France;Germany;Israel;Italy;Lebanon;Netherlands;Romania;Sweden;United Kingdom;Denmark
49NCT02889224February 201222 October 2018In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in ManIn Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in ManCushing's SyndromeOther: Control;Other: Hydrocortisone;Procedure: Hypercortisolism;Other: ObeseUniversity Hospital, BordeauxNot recruiting18 YearsN/AAll40N/AFrance
50NCT01374906November 4, 201111 June 2018Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's DiseaseA Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's DiseaseCushing's DiseaseDrug: pasireotide LAR;Drug: SOM230 LAR 30 mg;Drug: SOM230 LAR 10 mgNovartis PharmaceuticalsNot recruiting18 YearsN/AAll150Phase 3United States;Argentina;Belgium;Brazil;Canada;China;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Russian Federation;Spain;Thailand;Turkey;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2011-003264-77-NL31/10/201119 March 2012A 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 diseaseCushing'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
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Ketoconazole
Product Name: Ketoconazole
Product Code: RVG 08938
Pharmaceutical Form: Tablet
Trade Name: Cabergoline
Product Name: Cabergoline
Product Code: RVG 15375
Pharmaceutical Form: Tablet
Erasmus MCAuthorisedFemale: yes
Male: yes
Netherlands
52NCT01459237October 11, 201125 June 2018Effects of Hormone Stimulation on Brain Scans for Cushing s DiseaseProspective Evaluation of the Effect of Corticotropin-Releasing Hormone Stimulation on 18F-Fludeoxyglucose High-Resolution Positron-Emission Tomography in Cushing's DiseasePituitary NeoplasmDrug: ActhrelNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting8 YearsN/AAll30Early Phase 1United States
53EUCTR2010-024165-44-DE05/08/20115 February 2018An 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) - SeascapeCushing’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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
Current Sponsor code: SOM230B
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: Signifor
Product Name: Signifor
Product Code: SOM230 600µg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
Current Sponsor code: SOM230B
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-
Trade Name: Signifor
Product Name: Signifor
Product Code: SOM230 900µg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
Current Sponsor code: SOM230B
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 900-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
300Phase 3Czech Republic;Greece;Spain;Netherlands;Germany
54NCT01331239March 23, 201122 October 2019Safety and Efficacy of LCI699 in Cushing's Disease Patients.A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 Followed by a 12 - Week Treatment Period of LCI699 in Patients With Cushing's DiseaseCushing's DiseaseDrug: LCI699Novartis PharmaceuticalsNot recruiting18 Years75 YearsAll33Phase 2United States;France;Italy;Japan
55NCT01371565November 201019 October 2017Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's SyndromeCompassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's SyndromeCushing's Disease;Cushing's SyndromeDrug: MifepristoneCorcept TherapeuticsNot recruiting18 YearsN/AAll4Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2008-005708-18-GB04/06/201019 March 2012Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excessPrevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excessRheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndromeTrade Name: Glucophage (metformin)
Product Name: Metformin
Pharmaceutical Form: Tablet
Queen Mary University of LondonAuthorisedFemale: yes
Male: yes
United Kingdom
57EUCTR2010-018720-12-SE22/04/201023 September 2013Behandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom (treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergolineBehandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom (treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergolineA) 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
Pharmaceutical Form: Tablet
Swedish Pituitary Study groupAuthorisedFemale: yes
Male: yes
20Sweden
58JPRN-UMIN0000029252009/12/0122 July 2019Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension. - A pilot study to compare efficacy of Eplerenone monotherapy with Valsartan monotherapy.Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.50mg of Eplerenone monotherapy once daily for 6 weeks on subclinical Cushing's syndrome
80mg of Valsartan monotherapy once daily for 6 weeks on subclinical Cushing's syndrome
50mg of Eplerenone monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma
80mg of Valsartan monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma
Hiroshima University Hospital Department of Endocrinology and Diabetes mellitusNot Recruiting20years-oldNot applicableMale and Female80Not selectedJapan
59EUCTR2009-010918-30-IE11/08/200919 March 2012Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism.Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism.20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care.
MedDRA version: 9.1 Level: LLT Classification code 10021067 Term: Hypopituitarism
MedDRA version: 9.1 Level: LLT Classification code 10033662 Term: Panhypopituitarism
MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency
MedDRA version: 9.1 Level: LLT Classification code 10011318 Term: Craniopharyngioma
MedDRA version: 9.1 Level: LLT Classification code 10036832 Term: Prolactinoma
MedDRA version: 9.1 Level: LLT Classification code 10011651 Term: Cushing's disease
MedDRA version: 9.1 Level: LLT Classification code 10035104 Term: Pituitary tumour
MedDRA version: 9.1 Level: LLT Classification code 10061538 Term: Pituitary tumour benign
Trade Name: Genotropin 5.3mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 5.3-
Trade Name: Genotropin 12mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 12-
Trade Name: Genotropin Miniquick 0.2mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.2-
Trade Name: Genotropin Miniquick 0.4mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Trade Name: Genotropin Miniquick 0.6mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
Trade Name: Genotropin Miniquick 0.8mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.8-
Trade Name: Genotropin Miniquick 1.0mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Trade Name: Genotropin Miniquick 1.2mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.2-
Amar Agha, Beaumont HospitalAuthorisedFemale: yes
Male: yes
20Ireland
60NCT00936741July 200919 October 2017An Extension Study of CORLUX in the Treatment of Endogenous Cushing's SyndromeAn Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's SyndromeCushing's SyndromeDrug: mifepristoneCorcept TherapeuticsNot recruiting18 YearsN/AAll30Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2007-007604-15-GB03/03/200919 March 2012A Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical CushingsA Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical CushingsSub Clinical Cushing's Syndrome
MedDRA version: 9.1 Level: PT Classification code 10011652 Term: Cushing's syndrome
Trade Name: mifedren
Product Name: HRA052015 (mifepristone)
Product Code: HRA052015
Pharmaceutical Form: Tablet
INN or Proposed INN: MIFEPRISTONE
CAS Number: 84371653
Current Sponsor code: HRA052015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Sheffield Teaching Hospitals NHS Foundation TrustAuthorisedFemale: yes
Male: yes
6United Kingdom
62NCT00796783February 200919 February 2015A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of HypercortisolemiaA Study to Confirm the Presence of Recurrent or Persistent Cushing's Syndrome in Patients With Clinical Signs or Symptoms of Hypercortisolemia Who Have Been Treated for Cushing's DiseaseCushing's SyndromeDrug: Cushing's syndrome confirmationCorcept TherapeuticsNot recruiting18 YearsN/ABoth2N/AUnited States
63NCT00721201November 200819 February 2015Glucocorticoid Receptor Antagonism in Subclinical CushingsA Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical CushingsSubclinical Cushing'sDrug: MifepristoneSheffield Teaching Hospitals NHS Foundation TrustNot recruiting18 YearsN/ABoth6Phase 1/Phase 2United Kingdom
64NCT00845351November 200819 February 2015Preoperative Bexarotene Treatment for Cushing's DiseasePreoperative Bexarotene Treatment for Cushing's DiseaseCushing's DiseaseDrug: BexaroteneUniversity of VirginiaRecruiting18 Years65 YearsBoth6Phase 1/Phase 2United States
65EUCTR2008-006379-65-IT27/10/20083 April 2012Evaluation of the benefit-risk profile of retinoic acid in the treatment of Cushing`s disease - Retinoic acid in Cushing`s diseaseEvaluation of the benefit-risk profile of retinoic acid in the treatment of Cushing`s disease - Retinoic acid in Cushing`s diseasesperimentation only in patientsPharmaceutical Form: Capsule, hard
INN or Proposed INN: Tretinoin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
ISTITUTO AUXOLOGICO ITALIANOAuthorisedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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66EUCTR2008-002280-14-FR18/07/200819 March 2012Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trialComparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trialThe Active substance of Osteopor is Ossein Hydroxyapatite. Treatment of processes characterized by decalcification: osteoporosis, Cushing syndrome, thyrotoxicosis.
MedDRA version: 9.1 Level: LLT Classification code 10006956 Term: Calcium deficiency
Trade Name: OSTEOPOR
Product Name: OSTEOPOR
Product Code: L0006CP03A
Pharmaceutical Form: Tablet
INN or Proposed INN: ossein hydroxyapatite
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 830-
Trade Name: OROCAL
Product Name: OROCAL
Pharmaceutical Form: Tablet
INN or Proposed INN: calcium carbonate
CAS Number: 471341
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pierre Fabre MédicamentAuthorisedFemale: yes
Male: no
France
67NCT00569582December 200719 October 2017A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's SyndromeAn Open-label Study of the Efficacy and Safety of CORLUX (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's SyndromeCushing's SyndromeDrug: mifepristoneCorcept TherapeuticsNot recruiting18 YearsN/AAll50Phase 3United States
68NCT00889525November 200719 February 2015Study of Cabergoline in Treatment of Corticotroph Pituitary TumorStudy of Cabergoline in Treatment of Corticotroph Pituitary TumorCushing's Disease;Corticotroph AdenomaDrug: CabergolineSeth Gordhandas Sunderdas Medical CollegeNot recruiting12 YearsN/ABothPhase 3India
69EUCTR2006-004080-55-NL26/04/200719 March 2012Stepwise 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 DiseaseThe 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
Concentration unit: µg microgram(s)
Concentration type: equal
Trade Name: Dostinex
Product Name: Dostinex
Pharmaceutical Form: Tablet
INN or Proposed INN: CABERGOLINE
CAS Number: 81409907
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Trade Name: Nizoral
Product Name: Ketoconazole
Pharmaceutical Form: Tablet
INN or Proposed INN: KETOCONAZOLE
CAS Number: 65277421
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Erasmus MCAuthorisedFemale: yes
Male: yes
Netherlands
70NCT00612066April 200719 October 2017Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's DiseaseCushing's DiseaseDrug: rosiglitazone maleateJonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Not recruiting18 Years65 YearsAll2Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
71EUCTR2006-004111-22-DK05/01/200716 March 2015A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseCushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1 Level: LLT Classification code 10011651 Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-77-3
Current Sponsor code: SOM230 (di-aspartate)
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 300-900
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
146Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy
72EUCTR2006-004679-36-FR13/12/200622 December 2015Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EASTreatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
MedDRA version: 8.1 Level: LLT Classification code 10014155 Term: Ectopic corticotrophin syndrome
Product Code: HRA052015
Pharmaceutical Form: Tablet
INN or Proposed INN: mifepristone
CAS Number: 84371-65-3
Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Laboratoire HRA PharmaNot RecruitingFemale: yes
Male: yes
22France;Netherlands;Germany;Italy
73EUCTR2006-005218-11-IT15/09/200626 June 2012EFFECTIVENESS 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 SYNDROMECushing syndrome
MedDRA version: 9.1 Level: LLT Classification code 10011652 Term: Cushing's syndrome
Trade Name: DOSTINEX
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Trade Name: NIZORAL
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
ASSOCIAZIONE ITALIANA ENDOCRINOLOGIA-METABOLISMO-IPOFISIAuthorisedFemale: yes
Male: yes
Italy
74EUCTR2004-002407-32-IT21/10/200414 October 2013\\Extension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's diseaseTreatment of Cushing's disease
MedDRA version: 14.1 Level: PT Classification code 10035109 Term: Pituitary-dependent Cushing's syndrome System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: NA
Product Code: SOM230B
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE
CAS Number: 396091-77-3
Current Sponsor code: SOM230B
Concentration unit: µg microgram(s)
Concentration number: 900-
NOVARTIS FARMANot RecruitingFemale: yes
Male: yes
26United Kingdom;Italy
75NCT00088608April 200414 November 2016A Study to Assess SOM230 in Patients With Pituitary Cushing's DiseaseA Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's DiseaseCushing's SyndromeDrug: SOM230 s.c.Novartis PharmaceuticalsNot recruiting18 Years80 YearsBoth26Phase 2United States;France;Italy;United Kingdom
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
76NCT00001849February 26, 199920 May 2019New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing SyndromeNew Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's SyndromeCushing Syndrome;Endocrine DiseaseDrug: Pentetreotide;Drug: 18F-DOPAEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting18 Years90 YearsAll98Phase 1/Phase 2United States
77NCT00001180March 198219 February 2015Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal InsufficiencyDose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal InsufficiencyAdrenal Gland Hyperfunction;Adrenal Gland Hypofunction;Cushing's Syndrome;HealthyDrug: Ovine Corticotropin-Releasing Hormone (oCRH)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruitingN/AN/ABoth2250N/AUnited States

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