Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia

Summary

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.

Timeline

Start

2016-02-22

Primary completion

2018-07-28

Completion

2018-07-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Chronocort® vs Standard Glucocorticoid Therapy; p =0.5521; Mean Difference (Final Values) -0.069 (95% CI -0.299 to 0.161); ANCOVA NCT02716818 ↗

paper Although the study failed its primary outcome at 6 months PMID 33527139 ↗

Publications

• Merke DP, Mallappa A, Arlt W, Brac de la Perriere A, Linden Hirschberg A, Juul A, Newell-Price J, Perry CG, Prete A, Rees DA, Reisch N, Stikkelbroeck N, Touraine P, Maltby K, Treasure FP, Porter J, Ross RJ. Modified-Release Hydrocortisone in Congenital Adrenal Hyperplasia. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2063-e2077. doi: 10.1210/clinem/dgab051.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydrocortisone	Other / unclassified	—	Oral
Comparator	Dexamethasone	Small molecule	—	Oral
Comparator	Prednisolone	Other / unclassified	—	Oral
Comparator	Prednisone	Other / unclassified	—	Oral

Indications