A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.
- Conditions
- Congenital Adrenal Hyperplasia10001353
- Registration Number
- NL-OMON46149
- Lead Sponsor
- MediServ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
1. Known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with documented (at any time) elevated 17-hydroxyprogesterone (17-OHP) and/or androstenedione (A4) and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids) on a stable glucocorticoid therapy for a minimum of 6 months.
2. Male or female subjects aged 18 and above.
3. Provision of signed written informed consent.
4. Non-pregnant, non-lactating females who are post menopausal, naturally or surgically sterile, or of childbearing potential with a negative urinary pregnancy test and using a medically acceptable method of contraception. (Note: female subjects with oligomenorrhoea or amenorrhoea aged 55 or under should be considered potnetially fertile and therefore it is expected that they, besides undergoing pregnancy testing, should use an acceptable method of contraception.
5. Plasma renin activity (PRA) less than 1.5 times the upper limit of normal (ULN) at screening or within 3 months prior to screening, except in subjects who have been diagnosed with hypertension where the renin is not being used to monitor fludrocortisone replacement.
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. Subjects with any other significant medical or psychiatric conditions that in the opinion of the investigator would preclude participation in the trial.
5. History of malignancy (other than basal cell carcinoma successfully treated >6 months prior to entry into the study).
6. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study.
7. Subjects with a history of bilateral adrenalectomy.
8. Subjects having previously been exposed to Chronocort®.
9. Subjects working routinely in night shifts and therefore do not sleep during the usual night time.
10. Subjects unable to comply with the requirements of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate the superior efficacy of Chronocort® compared with standard<br /><br>glucocorticoid replacement therapy in the treatment of CAH based on 17-OHP.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In adult subjects with CAH:<br /><br>* To assess the safety and tolerability of Chronocort® treatment in adult<br /><br>subjects with CAH over a<br /><br>6-month period.<br /><br>* To assess the efficacy of Chronocort® with regard to the effect on A4 over<br /><br>the 6-month treatment period.<br /><br>* To assess the impact of Chronocort® on body composition (using dual energy<br /><br>X-ray absorbtimetry<br /><br>[DEXA]) * fat mass, lean mass and total bone density * at selected sites.</p><br>