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Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

NCT05063994 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-02-25

Study results available
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Summary

This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.

Conditions

  • Congenital Adrenal Hyperplasia

Interventions

DRUG

Chronocort

Over-encapsulated hydrocortisone modified-release capsule for oral administration.

DRUG

Cortef

Over-encapsulated hydrocortisone immediate-release tablet for oral administration.

OTHER

Placebo

Matching placebo

Sponsors & Collaborators

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · Neurocrine UK Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2024-02-02
Completion
2024-02-02
FDA Drug
Yes

Countries

  • United States
  • France
  • Japan

Study Locations

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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 NCT05063994 on ClinicalTrials.gov