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NCT00422201 · ClinicalTrials.gov registry record · Phase 2
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion
A Phase 2 study, sponsored by HRA Pharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00422201 is a Phase 2 study that was terminated before completion, run by HRA Pharma. The registered enrollment target is 18 participants.
The verdict
NCT00422201, a Phase 2 study, was terminated before completion, sponsored by HRA Pharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's syndrome occurs when the adrenal glands produce too much cortisol, a hormone that helps to regulate the body's use of salt and food. Excessive cortisol is usually the result of too much ACTH, the hormone that causes the adrenal glands to make cortisol. The extra ACTH is made either by a tumor in the pituitary gland (called Cushing's disease) or by a tumor somewhere else (called ectopic ACTH secretion). Mifepristone blocks the action of cortisol in the body. The drug has been used safely to treat a few people with Cushing's syndrome and patients with certain kinds of cancer, gynecological diseases and psychiatric disorders. People between 18 and 85 years of age with Cushing's syndrome caused by EXCESS ACTH secretion may be eligible for this study. Candidates are admitted to the hospital for evaluation to confirm Cushing's syndrome and to determine its cause. The evaluation includes blood and urine tests, imaging tests, dexamethasone and corticotropin-releasing hormone tests and inferior petrosal sinus sampling. Patients determined to have Cushing's syndrome due to ECTOPIC ACTH secretion undergo imaging studies (CT, MRI and a nuclear medicine scan) and begin mifepristone therapy. Participants remain in the hospital for the following tests and procedures: * Physical examination, electrocardiogram (EKG) and blood and urine tests * Completion of medical questionnaires * DEXA scan to determine bone mineral density and body composition * Glucose tolerance test * Urine pregnancy test and ultrasound to measure uterine lining thickness (for women) Patients take mifepristone by mouth 3 times a day. The dose is increased every week or so until symptoms improve or the highest dosage allowed is reached. Patients may remain in the hospital for all or part of the dose-finding part of the study. Du
Interventions
- DRUG Mifepristone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2007-05-15 |
| Est. Completion | 2012-04-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00422201
The ClinicalTrials.gov registry entry for NCT00422201 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HRA Pharma, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mifepristone is the first listed.
NCT00422201 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00422201 about?
NCT00422201 is a clinical study titled "Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion". This study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's syndrome occurs when the adrenal glands produce too much cortisol, a hormone that helps to regulate the body's use o...
What is the current status of trial NCT00422201?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2007-05-15. Estimated completion is 2012-04-04.
What interventions are being tested in trial NCT00422201?
The interventions under investigation include: Mifepristone (DRUG).
Who is sponsoring clinical trial NCT00422201?
This trial is sponsored by HRA Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
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