Phase 3Completed
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
A Phase III Study of Efficacy, Safety and Tolerability of Chronocort® Compared With Standard Glucocorticoid Replacement Therapy in the Treatment of Congenital Adrenal Hyperplasia
- Sponsor
- Neurocrine UK Limited (Industry)
- Enrolment
- 122 enrolled
- Conditions
- Congenital Adrenal Hyperplasia
- Interventions
- Chronocort®; standard glucocorticoid therapy
- Ages
- adults, older adults
- Registry
- NCT02716818
Full record on ClinicalTrials.gov
From the registry
This study is a parallel arm, randomised, open-label study, including dose titration and admissions for four overnight stays for 24-hour endocrine profiles. It will compare the efficacy, safety and tolerability of Chronocort® with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia (CAH) over a treatment period of 6 months. Dose titration decisions in both treatment groups will be made by a central independent physician, blinded to the treatment arm, using information generated from the 24-hour endocrine profiles. Each treatment arm will be subject to the same titration rules throughout the study, ensuring that opportunities for optimisation and control of androgens are the same in both groups.
Primary outcomes
- Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP
History
Last registry update
Results first posted
Primary completion
Registered
Started