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Corticosteroid

Hydrocortisone for Congenital Adrenal Hyperplasia

Phase 3
Waitlist Available
Led By Debbie Merke, MD
Research Sponsored by Diurnal Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with CAH who have successfully completed a clinical trial with the current formulation of Chronocort®.
Provision of signed written informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.5 years
Awards & highlights

Study Summary

This trial is for people with Chronocort® therapy or glucocorticoid therapy to see if they want to continue with their current treatment or switch to Chronocort®.

Eligible Conditions
  • Congenital Adrenal Hyperplasia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of Chronocort over time, as assessed by signs and symptoms of adrenal insufficiency.
Safety and tolerability of Chronocort, as assessed by change from pre-Chronocort® baseline in safety laboratory assessments.
Safety and tolerability of Chronocort, as assessed by change from pre-Chronocort® baseline in vital signs, weight, body mass index (BMI) and waist circumference.
+3 more
Secondary outcome measures
Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in SDS of A4.
Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in Standarad Deviation Score (SDS) of 17-OHP.
Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in absolute values of 17-OHP.
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chronocort®Experimental Treatment1 Intervention
Chronocort® modified release hydrocortisone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
2005
Completed Phase 4
~1260

Find a Location

Who is running the clinical trial?

Diurnal LimitedLead Sponsor
18 Previous Clinical Trials
729 Total Patients Enrolled
Debbie Merke, MDPrincipal InvestigatorNational Institutes of Health (NIH)
1 Previous Clinical Trials
122 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Mar 2025