Chronocort for Hyperplasia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hyperplasia+4 More
Chronocort - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for Congenital Adrenal Hyperplasia, which is a disorder that affects the adrenal glands. The new treatment is being compared to the standard treatment to see if it is more effective.

Eligible Conditions
  • Hyperplasia
  • Congenital adrenal hyperplasia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

3 Primary · 28 Secondary · Reporting Duration: 52 weeks (Assessed at baseline, 4, 10, 16, 34 and 52 weeks)

Week 34
To compare Chronocort to IRHC in terms of dose responders at 10, 16, and 34 weeks after randomization.
To compare Chronocort to IRHC in terms of total daily dose at 10, 16, and 34 weeks after randomization.
Week 52
To investigate the correlation between biochemical control at 10, 16, 34 and 52 weeks after randomization with the total daily dose at the corresponding timepoints.
Week 34
To compare Chronocort to IRHC in terms of biochemical responders at 4, 10, 16, and 34 weeks after randomization.
Week 52
To compare Chronocort to IRHC in terms of biochemical control at 10, 16, and 34 weeks after randomization.
To compare Chronocort to IRHC in terms of the impact on 17 OHP range.
To compare Chronocort to IRHC in terms of the impact on A4 range
To compare Chronocort to IRHC in terms of the impact on glucocorticoid dose - Total daily dose
To compare Chronocort to IRHC in terms of the impact on mean 17-OHP and A4
52 weeks
To assess compliance over the study period.
To assess dose changes over the study period - Change in mg
To assess dose changes over the study period - Incidence
To assess dose changes over the study period.
To assess preference for treatment.
To assess the need for use of additional glucocorticoid doses by recording of use of stress dosing rules - Dose of steroid
To assess the need for use of additional glucocorticoid doses by recording of use of stress dosing rules - Duration of use
To assess the need for use of additional glucocorticoid doses by recording of use of stress dosing rules - Incidence of use
To assess the need for use of additional glucocorticoid doses by recording of use of stress dosing rules.
To assess the safety and tolerability of Chronocort relative to IRHC.
To compare Chronocort to IRHC in terms of biochemical responder rate after 52 weeks of randomized treatment - 17-OHP concentration
To compare Chronocort to IRHC in terms of biochemical responder rate after 52 weeks of randomized treatment - A4 concentration
To compare Chronocort to IRHC in terms of biochemical responder rate after 52 weeks of randomized treatment - Total daily dose of Hydrocortisone
To compare Chronocort to IRHC in terms of dose responder rate after 52 weeks of randomized treatment - 17-OHP concentration
To compare Chronocort to IRHC in terms of dose responder rate after 52 weeks of randomized treatment - A4 concentration
To compare Chronocort to IRHC in terms of dose responder rate after 52 weeks of randomized treatment - Total daily dose
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment
Therapeutic procedure
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - Body weight
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - HbA1c
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - Hirsutism
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - LH Level
Therapeutic procedure
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - Multidimensional Assessment of Fatigue (MAF)
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - SF-36®
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - Sperm Count
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - TART size
To compare Chronocort to IRHC in terms of net clinical benefit after 52 weeks of randomized treatment - Waist Circumference
To compare Chronocort to IRHC in terms of the impact on 11 ketotestosterone.
To compare Chronocort to IRHC in terms of the impact on dehydroepiandrosterone (DHEA)
To compare Chronocort to IRHC in terms of the impact on glucocorticoid dose - Biochemical control
To compare Chronocort to IRHC in terms of the impact on total testosterone
To compare Chronocort to IRHC in terms of total daily dose after 52 weeks of randomized treatment.
Week 52
To evaluate the safety of Chronocort compared to IRHC by assessment of electrocardiogram (ECG) by number of patients with changes in ECG.
To evaluate the safety of Chronocort compared to IRHC by assessment of physical examination by number of participants with changes in physical examination.
Week 52
To evaluate the safety of Chronocort compared to IRHC by assessment of safety laboratory assessments by number of participants with changes in safety laboratory assessments.
To evaluate the safety of Chronocort compared to IRHC by assessment of vital signs by number of patients with changes in vital signs.
Week 52
To compare Chronocort to IRHC in terms of the impact on sperm count.
To compare Chronocort to IRHC in terms of the impact on testicular adrenal rest tumors (TART) size.
Week 52
To compare Chronocort to IRHC in terms of changes in menstrual regularity.
To compare Chronocort to IRHC in terms of the impact on QoL using the EuroQol 5 level Standardized Health Questionnaire (EQ-5D-5L™).
To compare Chronocort to IRHC in terms of the impact on QoL using the Multidimensional Assessment of Fatigue (MAF).
To compare Chronocort to IRHC in terms of the impact on QoL using the remaining self-completed SF-36® sub domains (excluding vitality).
To compare Chronocort to IRHC in terms of the impact on Quality of Life (QoL) using the self-completed Medical Outcome Study 36-Item Short Form Health Survey (SF-36®) total score and the sub domain of vitality.
To compare Chronocort to IRHC in terms of the impact on alertness.
To compare Chronocort to IRHC in terms of the impact on body weight.
To compare Chronocort to IRHC in terms of the impact on follicle stimulating hormone (FSH) levels.
To compare Chronocort to IRHC in terms of the impact on luteinizing hormone (LH) levels.
To compare Chronocort to IRHC in terms of the impact on objective acne in female participants
To compare Chronocort to IRHC in terms of the impact on objective hirsutism in female participants
To compare Chronocort to IRHC in terms of the impact on subjective acne in female participants.
To compare Chronocort to IRHC in terms of the impact on subjective hirsutism in female participants
To compare Chronocort to IRHC in terms of the impact on the bone marker of osteocalcin.
To compare Chronocort to IRHC in terms of the impact on waist circumference.
Week 52
To compare Chronocort to IRHC in terms of the impact on glycated hemoglobin (HbA1c) levels.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Cortef
21%Headache
This histogram enumerates side effects from a completed 2009 Phase 1 & 2 trial (NCT00519818) in the Cortef ARM group. Side effects include: Headache with 21%.

Trial Design

2 Treatment Groups

Cortef
1 of 2
Chronocort
1 of 2
Active Control
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Chronocort · No Placebo Group · Phase 3

Chronocort
Drug
Experimental Group · 1 Intervention: Chronocort · Intervention Types: Drug
Cortef
Drug
ActiveComparator Group · 1 Intervention: Cortef · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks (assessed at baseline, 4, 10, 16, 34 and 52 weeks)

Who is running the clinical trial?

Diurnal LimitedLead Sponsor
18 Previous Clinical Trials
766 Total Patients Enrolled
8 Trials studying Hyperplasia
489 Patients Enrolled for Hyperplasia
D MerkePrincipal InvestigatorNational Institutes of Health Clinical Center, Bethesda, Maryland, US
1 Previous Clinical Trials
181 Total Patients Enrolled
1 Trials studying Hyperplasia
181 Patients Enrolled for Hyperplasia

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and you are of childbearing potential
You are female and not pregnant, not breastfeeding, and you are either not a woman of childbearing potential (WOCBP) or have a negative pregnancy test at entry into the study.
You must be 16 years or older to participate in this study.
You have a height velocity of less than 2 cm/year in the last year and puberty must be completed (Tanner stage V).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.