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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 is a Phase 2 study that has completed, run by Neurocrine UK Limited. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01735617
The ClinicalTrials.gov registry entry for NCT01735617 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 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 1 intervention - of which Hydrocortisone Modified Release Capsules is the first listed.
NCT01735617 reports 0 study locations.
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.
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