Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency

Summary

This study is a double-blind, double-dummy, two-way cross-over, randomised, Phase II study to be conducted at approximately 6 investigational sites in 2 countries. The study will compare the efficacy, safety and tolerability of twice daily Chronocort, a modified-release hydrocortisone, with once daily Plenadren, a modified-release hydrocortisone, over a treatment period of up to 2 months in participants aged 18 years and over, diagnosed with primary Adrenal Insufficiency (AI).

Timeline

Start

2021-11-23

Primary completion

2023-10-18

Completion

2023-10-18

Publications

• Prete A, Theiler-Schwetz V, Arlt W, Hazeldine J, Chifu IO, Harbeck B, Napier C, Newell-Price JDC, Rees DA, Reisch N, Stalla GK, Coope H, Maltby K, Porter J, Quirke J, Ross RJ. Effects of modified release hydrocortisone on restoration of early morning cortisol, quality of life, and fatigue in adrenal insufficiency (The CHAMPAIN study): a randomised, double-blind, double-dummy, cross-over study comparing Chronocort and Plenadren. EClinicalMedicine. 2026 Jan 2;91:103714. doi: 10.1016/j.eclinm.2025.103714. eCollection 2026 Jan.

Drugs

Indications