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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 is a Phase 3 study that has completed, run by Neurocrine UK Limited. The registered enrollment target is 122 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02716818
The ClinicalTrials.gov registry entry for NCT02716818 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine UK Limited, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Chronocort® is the first listed.
NCT02716818 reports 0 study locations.
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.
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