NCT03532022

Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy

An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal Hyperplasia (CAH). This study will be conducted in the USA.

Detailed description

It will compare the efficacy, safety and tolerability of twice daily Chronocort® with standard care (using the participant's usual individualized standard glucocorticoid regimen) over a treatment period of 52 weeks in participants aged 16 years and over with known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with documented (at any time) elevated 17-OHP or A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids).

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Chronocort®	Hydrocortisone modified release capsules - 5mg, 10mg and 20mg.
DRUG	Standard Care	The subject's standard care regimen upon entering the study; this could consist of hydrocortisone, dexamethasone, prednisone or prednisolone.

Timeline

• Start date: 2018-10-04
• Primary completion: 2018-10-17
• Completion: 2021-07-09
• First posted: 2018-05-22
• Last updated: 2022-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study