CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
hydrocortisone (modified release), oral tablet 20 and 5 mg +1 moredrug
Likely dose
hydrocortisone (modified release), oral tablet 20 and 5 mgfrom 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/NCT00915343
NCT00915343Phase 3Completed
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A, Randomised, Controlled, Two-armed, Two-period Cross-over, Multi-centre Phase II/III Study to Assess the Safety and Pharmacokinetics of Once-daily Oral Modified-release Hydrocortisone in Patients With Adrenal Insufficiency

Shire·interventional·Posted Jun 8, 2009·Updated Nov 24, 2020

In Brief

A Phase 3 clinical trial evaluating hydrocortisone (modified release), oral tablet 20 and 5 mg and Hydrocortisone, oral tablet, 10 mg for Adrenal Insufficiency. Completed, enrolled 64 participants.

Detailed Summary

This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdrenal Insufficiency
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2009
Enrollment StartAug 21, 2007
Primary CompletionJul 28, 2008
Study CompletionJan 28, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.1 years ago

Interventions

hydrocortisone (modified release), oral tablet 20 and 5 mgdrug

The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state. The dose was the same as patients have had before entering the trial

Hydrocortisone, oral tablet, 10 mgdrug

The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM). The morning dose was administered in the fasting state. The total daily dose was the same as in the experimental treatment arm.