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COMPLETED
NCT05222152
PHASE2

Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency

Sponsor: Neurocrine UK Limited

View on ClinicalTrials.gov

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).

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2021-11-23

Completion Date

2023-10-18

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DRUG

Chronocort

Hydrocortisone modified-release hard gelatin capsules for oral administration - 5mg and 10mg

DRUG

Plenadren

Hydrocortisone modified-release tablets for oral administration - 5mg and 20mg

Locations (8)

Diurnal Investigational Site in Hamburg

Hamburg, Germany

Diurnal Investigational Site in Munich

Munich, Germany

Diurnal Investigational Site in Munich

Munich, Germany

Diurnal Investigational Site in Würzburg

Würzburg, Germany

Diurnal Investigational Site in Birmingham

Birmingham, United Kingdom

Diurnal Investigational Site in Cardiff

Cardiff, United Kingdom

Diurnal Investigational Site in Newcastle

Newcastle, United Kingdom

Diurnal Investigational Site in Sheffield

Sheffield, United Kingdom