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 | NCT05436639 (ClinicalTrials.gov) | June 9, 2022 | 23/6/2022 | SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor | SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor | Autonomous Cortisol Secretion (ACS);ACTH-Independent Cushing Syndrome;ACTH-Independent Adrenal Cushing Syndrome, Somatic | Drug: SPI-62 dose1;Drug: SPI-62 dose 2;Drug: SPI-62 dose 3;Drug: SPI-62 dose 4;Drug: Placebo | Sparrow Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 2 | United States;Bulgaria;France;Romania;United Kingdom;Germany;Italy |
| 2 | NCT04045015 (ClinicalTrials.gov) | October 16, 2018 | 1/8/2019 | Liquorice and Salivary Cortisol | Effects of Liquorice on Salivary Cortisol and Cortisone | Cushing Syndrome;Hypercortisolism | Dietary Supplement: Liqourice | Umeå University | NULL | Recruiting | 18 Years | 65 Years | All | 30 | N/A | Sweden |
| 3 | JPRN-UMIN000041513 | 2014/07/01 | 01/09/2020 | A new perioperative glucocorticosteroid replacement therapy for cushing syndrome | A new perioperative glucocorticosteroid replacement therapy for cushing syndrome - A perioperative glucocorticosteroid replacement therapy | Perioperative | Hydrocortisone was given during adrenal resection by intravenous injectionon the surgical day. | Tianjin Medical University General Hospital | NULL | Recruiting | 22years-old | 61years-old | Male and Female | 80 | Not selected | Asia(except Japan) |
| 4 | EUCTR2013-002133-37-ES (EUCTR) | 26/05/2014 | 12/11/2013 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have a medical condition in which they produce too much of a steriod hormone known as cortisol | An Open Label Study to Assess the Safety and Efficiacy of COR-003 (2S,4R- Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome (CS) Estudio abierto para evaluar la seguridad y la eficacia del producto COR-003 (2S, 4R-ketoconazol) en el tratamiento del síndrome de Cushing endógeno (SC) | Endogenous Cushing's syndrome (CS) MedDRA version: 16.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Germany;China;Sweden | ||
| 5 | EUCTR2009-010918-30-IE (EUCTR) | 11/08/2009 | 11/03/2009 | 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. | 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;Classification code 10033662;Term: Panhypopituitarism MedDRA version: 9.1;Classification code 10056438;Term: Growth hormone deficiency MedDRA version: 9.1;Classification code 10011318;Term: Craniopharyngioma MedDRA version: 9.1;Classification code 10036832;Term: Prolactinoma MedDRA version: 9.1;Classification code 10011651;Term: Cushing's disease MedDRA version: 9.1;Classification code 10035104;Term: Pituitary tumour MedDRA version: 9.1;Classification code 10061538;Term: Pituitary tumour benign | Trade Name: Genotropin 5.3mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin 12mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.2mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.4mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.6mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.8mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 1.0mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 1.2mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniqu | Amar Agha, Beaumont Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Ireland | |||
| 6 | EUCTR2006-004111-22-HU (EUCTR) | 29/10/2008 | 22/07/2008 | A 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 disease | A 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 disease | Cushing’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 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 7 | EUCTR2006-004111-22-GB (EUCTR) | 19/03/2008 | 20/03/2008 | A 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 disease | A 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 disease | Cushing’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 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Phase 3 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2006-004111-22-GR (EUCTR) | 11/12/2007 | 30/07/2007 | A 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 disease | A 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 disease | Cushing’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 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 9 | EUCTR2006-004111-22-PT (EUCTR) | 09/11/2007 | 27/06/2007 | A 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 disease | A 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 disease | Cushing’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 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy | |||
| 10 | EUCTR2006-004111-22-FI (EUCTR) | 04/05/2007 | 24/01/2007 | A 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 disease | A 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 disease | Cushing’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 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy | |||
| 11 | EUCTR2006-004111-22-DE (EUCTR) | 04/04/2007 | 18/04/2007 | A 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 disease | A 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 disease | Cushing’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: SOM230 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 12 | EUCTR2006-004111-22-FR (EUCTR) | 23/03/2007 | 12/02/2007 | A 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 disease | A 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 disease | Cushing’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 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotode Other descriptive name: Cyclo ((diaminoethyl-carbamate)HyPro-Phg-(D) Trp-Ly di-aspartate Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide Other descriptive name: Cyclo ((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Ly di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 13 | EUCTR2006-004111-22-BE (EUCTR) | 06/03/2007 | 14/11/2006 | A 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 disease | A 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 disease | Cushing’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: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders | Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Phase 3 | Denmark;Germany;United Kingdom;Italy;Portugal;France;Hungary;Greece;Finland;Spain;Belgium | ||
| 14 | EUCTR2006-004111-22-ES (EUCTR) | 05/02/2007 | 11/08/2014 | A 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 disease | A 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 disease | Cushing?s disease is a 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 a rare disease associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females. MedDRA version: 17.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Farmaceútica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Portugal;United States;Greece;Finland;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China | |||
| 15 | EUCTR2006-004111-22-DK (EUCTR) | 05/01/2007 | 10/11/2006 | A 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 disease | A 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 disease | Cushing’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 INN or Proposed INN: pasireotide Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 16 | EUCTR2004-002407-32-GB (EUCTR) | 13/01/2005 | 27/06/2005 | 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 disease | 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 disease | Cushing’s disease is an endocrine disease that is caused by an Adrenocorticotropic hormone (ACTH) secreting pituitary adenoma, which is a benign tumor of the pituitary gland. This elevated ACTH stimulates the adrenal glands to produce excess cortisol and subsequent development of the clinical signs and symptoms which include: upper body obesity, severe fatigue and muscle weakness, high blood pressure, backache, elevated blood sugar, and menstrual disorders in women | Product Code: SOM230B INN or Proposed INN: Pasireotide Other descriptive name: Cyclo(diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) | Novartis Pharmaceuticals UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 26 | Italy;United Kingdom |