Chronocort versus Plenadren replacement therapy in adults with adrenal insufficiency
Research type
Research Study
Full title
A Double-Blind, Double-Dummy, Two-Way Cross-Over, Randomised, Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisones: Chronocort® Versus Plenadren®, in Adrenal Insufficiency
IRAS ID
1003971
Contact name
Richard Ross
Contact email
Sponsor organisation
Diurnal Limited
Eudract number
2021-000144-21
Clinicaltrials.gov Identifier
Research summary
Chronocort® (Diurnal) is an oral formulation of hydrocortisone, designed to match normal serum levels of cortisol by replicating the normal overnight increase in cortisol levels and providing physiological levels upon waking. It is anticipated that providing a near physiological circadian rhythm of cortisol will improve the general health of patients with adrenal insufficiency (AI) who are receiving glucocorticoid replacement therapy. The primary purpose of this research study is to see whether Chronocort, compared to a similar product Plenadren, is better able to improve the pattern of cortisol release to reflect normal physiological cortisol levels. The secondary purpose is to determine whether improved cortisol levels will reduce fatigue and improve quality of life.
Subjects will be given Chronocort for 4 weeks and Plenadren for 4 weeks. The order in which subjects receive the two treatments is decided at random. Both subjects and study doctors will not know which treatment subjects are taking and in which order.REC name
South Central - Oxford C Research Ethics Committee
REC reference
21/SC/0275
Date of REC Opinion
12 Oct 2021
REC opinion
Further Information Favourable Opinion