Chronocort for Hyperplasia
Phase-Based Progress Estimates
Effectiveness
Safety
Hyperplasia+4 More
Chronocort - DrugEligibility
Any Age
All Sexes
What conditions do you have?
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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
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
This is further along than 85% of similar trials
Side Effects for
Cortef
21%Headache
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: DrugCortef
Drug
ActiveComparator Group · 1 Intervention: Cortef · Intervention Types: DrugTreatment
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 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.
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