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NCT00519818 · ClinicalTrials.gov registry record · Phase 1
Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
A Phase 1 study of Congenital Adrenal Hyperplasia and 21-Hydroxylase Deficiency, sponsored by Neurocrine UK Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00519818 is a Phase 1 study of Congenital Adrenal Hyperplasia and 21-Hydroxylase Deficiency that has completed, run by Neurocrine UK Limited. The registered enrollment target is 20 participants, below the 100-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00519818, a Phase 1 study of Congenital Adrenal Hyperplasia and 21-Hydroxylase Deficiency, has completed, sponsored by Neurocrine UK Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test a new, extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and prednisone) are currently used to treat CAH, but finding the best dose of these drugs that effectively lowers androgens without causing undesirable side effects, such as weight gain and slow growth rate in children, is often difficult to achieve. Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this study. Children 16 years of age and older are eligible with confirmation by bone age that they are no longer growing. Participants undergo the following tests and procedures during two inpatient visits one month apart at the NIH Clinical Center: * Medical history and physical examination. * Medications: Following 7 days of Cortef (standard drug treatment for CAH), patients begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day for 1 month. * Blood tests: A catheter (plastic tube) is inserted in a vein and left in place for frequent blood draws in order to avoid repeated needlesticks. Blood is drawn for chemistries, blood count, pregnancy test in women, and for serial tests (up to 26 samples in a 24-hour period) to measure hormone levels. * 24-hour urine test. * Height and weight measurements. Between the two hospitalizations, patients are contacted by NIH weekly to check for possible side effects from Chronocort. Two weeks after the first visit, patients also will have blood drawn by their regular doctor or a local clinic. A few days before the second hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and well being. About 30 days after discharge from the second hospitalization, patients are followed up wi
Conditions Studied
Interventions
- DRUG Chronocort
- DRUG Cortef
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00519818
The ClinicalTrials.gov registry entry for NCT00519818 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (80% lower). The listed sponsor is Neurocrine UK Limited, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Congenital Adrenal Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which Chronocort is the first listed.
NCT00519818 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00519818 about?
NCT00519818 is a clinical study titled "Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia". This study will test a new, extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex hormone androgen. Medici...
What is the current status of trial NCT00519818?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-08. Estimated completion is 2009-05.
What conditions does trial NCT00519818 study?
This clinical trial studies the following conditions: Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency, Adrenogenital Syndrome.
What interventions are being tested in trial NCT00519818?
The interventions under investigation include: Chronocort (DRUG), Cortef (DRUG).
Who is sponsoring clinical trial NCT00519818?
This trial is sponsored by Neurocrine UK Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00519818 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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