EUCTR2015-005448-32-DK
Active, not recruiting
Phase 1
A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Diurnal Ltd
- Enrollment
- 136
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects with congenital adrenal hyperplasia (CAH) who have successfully completed the DIUR\-003 or DIUR\-005 clinical trials with the current formulation of Chronocort®
- •2\. Provision of signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 136
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Co\-morbid condition requiring daily administration of a medication (or consumption of any material) that interferes with the metabolism of glucocorticoids
- •2\. Clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the ULN or elevated liver function tests (ALT or AST \>2 times the ULN)
- •3\. Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication other than CAH
- •4\. History of malignancy (other than basal cell carcinoma successfully treated \>6 months prior to entry into the study)
- •5\. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study
- •6\. Subjects with a history of bilateral adrenalectomy
- •7\. Subjects unable to comply with the requirements of the protocol.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
The 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.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: 100000004850Therapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2015-005448-32-SEDiurnal Ltd138
Active, not recruiting
Phase 1
The 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.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: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2015-005448-32-DEDiurnal Ltd136
Active, not recruiting
Phase 1
The 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.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: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2015-005448-32-GBDiurnal Ltd136
Completed
Phase 3
A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.prostate cancer that can't be treated surgically1003859710036958NL-OMON43687Celgene Corporation136
Active, not recruiting
Phase 3
A phase 3 study to evaluate the efficacy and safety of ARO-APOC3 in adults with familial chylomicronemia syndromeFamilial Chylomicronemia SyndromeGenetic DiseasesISRCTN12904794Arrowhead Pharmaceuticals, Inc.76