Cortisol    (DrugBank: Cortisol)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
81先天性副腎皮質酵素欠損症14

81. 先天性副腎皮質酵素欠損症 [臨床試験数:65,薬物数:77(DrugBank:20),標的遺伝子数:11,標的パスウェイ数:65
Searched query = "Congenital adrenal hyperplasia", "Congenital adrenal enzyme deficiency", "Congenial adrenal cortex enzyme deficiency", "Congenital Lipoid Adrenal Hyperplasia", "3β-Hydroxysteroid Dehydrogenase Deficiency", "21-Hydroxylase deficiency", "11β-Hydroxylase deficiency", "17α-Hydroxylase deficiency", "P450 oxidoreductase deficiency", "Aldosterone synthase deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
14 / 65 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004802-24-NL
(EUCTR)
20/05/201913/05/2019Avoiding over and undertreatment by optimizing of the timing ofglucocorticoïd treatment in children with cnogenital adrenal hyperplasiaOptimizing timing of glucocorticoid treatment in children with congenitaladrenal hyperplasia - OPTIMED study Congenital adrenal hyperplasia (CAH) is a disorder of adrenal steroidsynthesis leading to cortisol deficiency and an increase in androgenproduction.Treatment in children consists of hydrocortisone substitutionthereby also restoring the negative feedback on the pituitary gland andconsequently normalize androgen production. There is still no evidenceabout the best timing of hydrocortisone use: The highest dosage ofhydrocortisone in the morning or the highest dosage at night;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Hydrocortisone
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Radboud University Nijmegen Medical CentreNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Netherlands
2EUCTR2015-005448-32-DK
(EUCTR)
01/09/201728/06/2017The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
3EUCTR2015-005448-32-SE
(EUCTR)
09/02/201706/09/2016The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Diurnal LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
138 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Germany;United Kingdom;Sweden
4EUCTR2015-005448-32-DE
(EUCTR)
31/01/201702/11/2016The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Diurnal LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
136 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
5EUCTR2015-000711-40-DK
(EUCTR)
08/09/201611/07/2016Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 10mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 0,1 mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 2,5 mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Product Name: Hydrocortisone tablet 2.5 mg
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-005448-32-GB
(EUCTR)
20/07/201605/07/2016The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Diurnal LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
7EUCTR2015-000711-40-DE
(EUCTR)
23/05/201606/10/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Diurnal LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
8EUCTR2015-000711-40-NL
(EUCTR)
28/04/201617/11/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 18.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 1,5 mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 5 mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Denmark;Germany;Netherlands;United Kingdom;Sweden
9EUCTR2015-000711-40-SE
(EUCTR)
11/01/201613/10/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 2mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 1mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
10EUCTR2015-000711-40-GB
(EUCTR)
19/11/201528/07/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Diurnal LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-000458-40-DE
(EUCTR)
20/10/201521/08/2015Open-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 studyOpen-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 study - Infacort004 Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Current standard treatment in neonates is unsatisfactory, as unlicensed and crushed adult dosage formulations (Hydrocortisone tablets,10 mg) are used. Infacort® is a new paediatric and neonatal formulation of hydrocortisone that is provided in appropriate unit dosage (0.5mg, 1.0mg, 2.0mg and 5mg);Therapeutic area: Diseases [C] - Hormonal diseases [C19]Diurnal LimitedNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany
12EUCTR2014-002265-30-DE
(EUCTR)
19/02/201523/12/2014A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency.A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency. Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Current standard treatment in neonates is unsatisfactory, as unlicensed and crushed adult dosage formulations (Hydrocortisone tablets, 10 mg) are used. Infacort® is a new paediatric and neonatal formulation of hydrocortisone that is provided in appropriate unit dosage (0.5mg, 1.0mg, 2.0mg and 5mg).;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Diurnal LimitedNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
13EUCTR2012-001104-37-GB
(EUCTR)
06/10/201424/07/2014pulses studyPulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia - the pulses study Addison's disease and Congenital Adrenal Hyperplasia
MedDRA version: 17.0;Level: LLT;Classification code 10011195;Term: Cortisol;System Organ Class: 100000004848
MedDRA version: 17.0;Classification code 10020518;Term: Hydrocortisone;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: hydrocortisone sodium phosphate
Product Name: hydrocortisone sodium phosphate
INN or Proposed INN: hydrocortisone sodium phosphate
Trade Name: hydrocortisone
Product Name: hydrocortisone
INN or Proposed INN: hydrocortisone
University Hospitals Bristol NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
14NCT01859312
(ClinicalTrials.gov)
May 6, 201317/5/2013Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal HyperplasiaA Pilot Study Assessing the Use of Continuous Subcutaneous Hydrocortisone Infusion in the Treatment of Congenital Adrenal HyperplasiaAdrenal Insufficiency;Excess Androgen;Congenital Adrenal Hyperplasia (CAH)Drug: Hydrocortisone (Solucortef);Device: Insulin pump (Medtronic)National Institutes of Health Clinical Center (CC)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed18 Years99 YearsAll8Phase 2United States