CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Chronocort +1 moredrug
Likely dose
Chronocort 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05222152
NCT05222152Phase 2Completed
CompareCT.gov

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

Neurocrine UK Limited·interventional·Posted Feb 3, 2022·Updated May 14, 2024

In Brief

A Phase 2 clinical trial evaluating Chronocort and Plenadren for Primary Adrenal Insufficiency. Completed, enrolled 58 participants across 8 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Adrenal Insufficiency
CountriesGermany, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedFeb 3, 2022
Enrollment StartNov 23, 2021
Primary CompletionOct 18, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.4 years ago

Interventions

Chronocortdrug

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

Plenadrendrug

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