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NCT02716818 · ClinicalTrials.gov registry record · Phase 3
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
A Phase 3 study, sponsored by Neurocrine UK Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT02716818: Completed Phase 3 study, sponsored by Neurocrine UK Limited.
NCT02716818 is a Phase 3 study that has completed, run by Neurocrine UK Limited. The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02716818, a Phase 3 study, has completed, sponsored by Neurocrine UK Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study Summary
This study is a parallel arm, randomised, open-label study, including dose titration and admissions for four overnight stays for 24-hour endocrine profiles. It will compare the efficacy, safety and tolerability of Chronocort® with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia (CAH) over a treatment period of 6 months. Dose titration decisions in both treatment groups will be made by a central independent physician, blinded to the treatment arm, using information generated from the 24-hour endocrine profiles. Each treatment arm will be subject to the same titration rules throughout the study, ensuring that opportunities for optimisation and control of androgens are the same in both groups.
Primary Outcome
Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP (17-Hydroxyprogesterone). The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transfor
Interventions
- DRUG Chronocort®
- DRUG standard glucocorticoid therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2016-02-22 |
| Est. Completion | 2018-07-28 |
| Phase | Phase 3 |
What the finished NCT02716818 record still lists
NCT02716818 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Chronocort® is the first listed.
NCT02716818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02716818 about?
NCT02716818 is a clinical study titled "Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia". This study is a parallel arm, randomised, open-label study, including dose titration and admissions for four overnight stays for 24-hour endocrine profiles. It will compare the efficacy, safety and tolerability of Chronocort® with standard glucocorticoid replacement therapy in the treatment of conge...
What is the current status of trial NCT02716818?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2016-02-22. Estimated completion is 2018-07-28.
What interventions are being tested in trial NCT02716818?
The interventions under investigation include: Chronocort® (DRUG), standard glucocorticoid therapy (DRUG).
Who is sponsoring clinical trial NCT02716818?
This trial is sponsored by Neurocrine UK Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02716818's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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