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Corticosteroid

A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH

Phase 3
Waitlist Available
Led By Principal Investigator
Research Sponsored by Diurnal Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4 and month 18-24
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial offers patients from previous studies the opportunity to continue or switch to Chronocort® therapy. Chronocort® helps by providing a steady supply of cortisol, a hormone that regulates various body functions. The goal is to mimic the body's natural hormone cycles for better health outcomes. Chronocort is a modified-release formulation of hydrocortisone designed to mimic the body's natural cortisol circadian rhythm.

Eligible Conditions
  • Congenital Adrenal Hyperplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 4 and month 18-24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 4 and month 18-24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Maximum Values
Safety Laboratory Assessments - Number of Participants With a Shift in Laboratory Parameters Baseline Values to the Minimum Values
Safety and Tolerability - Change From Pre-Chronocort Baseline to Month 30 in Vital Signs - BMI
+11 more
Secondary study objectives
Change From Pre-Chronocort Baseline at Month 24 in Body Composition - Bone Mineral Density
Change From Pre-Chronocort Baseline at Month 24 in Body Composition - Total Fat Mass
Change From Pre-Chronocort Baseline at Month 24 in Body Composition - Total Lean Mass
+16 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1280

Find a Location

Who is running the clinical trial?

Diurnal LimitedLead Sponsor
18 Previous Clinical Trials
615 Total Patients Enrolled
Principal InvestigatorPrincipal InvestigatorDiurnal Limited
39 Previous Clinical Trials
5,011 Total Patients Enrolled
Debbie Merke, MDPrincipal InvestigatorNational Institutes of Health (NIH)
1 Previous Clinical Trials
122 Total Patients Enrolled
~10 spots leftby Dec 2025
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