MedTrace Logo

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

NCT03532022 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-04-08

No results posted yet for this study

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.

Conditions

  • Congenital Adrenal Hyperplasia

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Neurocrine UK Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2018-10-17
Completion
2021-07-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532022 on ClinicalTrials.gov