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NCT01735617 · ClinicalTrials.gov registry record · Phase 2
Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH
A Phase 2 study, sponsored by Neurocrine UK Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01735617: Completed Phase 2 study, sponsored by Neurocrine UK Limited.
NCT01735617 is a Phase 2 study that has completed, run by Neurocrine UK Limited. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01735617, a Phase 2 study, has completed, sponsored by Neurocrine UK Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone cortisol, which is released in the body following a regular daily pattern. The objective of the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream once Chronocort® is taken and what affects it has on other hormones in the body. Since Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is hoped that patients with CAH will be treated more effectively to manage their disease.
Primary Outcome
The maximum plasma concentration (Cmax) of chronocort
Interventions
- DRUG Hydrocortisone Modified Release Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01735617 record still lists
NCT01735617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydrocortisone Modified Release Capsules is the first listed.
NCT01735617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01735617 about?
NCT01735617 is a clinical study titled "Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH". The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone cortisol, which is released in ...
What is the current status of trial NCT01735617?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2012-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01735617?
The interventions under investigation include: Hydrocortisone Modified Release Capsules (DRUG).
Who is sponsoring clinical trial NCT01735617?
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 NCT01735617's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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