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NCT00603109 · ClinicalTrials.gov registry record · Phase 3
Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome
A Phase 3 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 10
- Enrollment target
NCT00603109 is a Phase 3 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 10 participants.
The verdict
NCT00603109, a Phase 3 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1 blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects with Prader-Willi Syndrome (PWS). This will be a double blind placebo controlled clinical trial involving a total of 18 young adults aged 18 to 35 years with PWS. Patients will be divided in to the two groups of control and intervention, and treated with either placebo (inactive drug), or rimonabant 20 mg once a day for a total duration of 6 months. Body weight, fat distribution, objective and subjective assessment of the hunger, fasting blood sample for measurement of ghrelin and leptin (two hormones regulating appetite), serum lipids , IGF-1(growth hormone related protein), insulin and glucose concentrations will be measured upon enrollment, at 3 months, and at the end of the study. The proportion of body fat to muscle will be determined using a radiological technique, whole body dual-energy x-ray absorptiometry (DEXA) scan, and also by measurement of skin fold thickness, waist and hip circumference at the enrollment prior to the intervention, and at the end of the study.
Interventions
- DRUG placebo
- DRUG rimonabant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00603109
The ClinicalTrials.gov registry entry for NCT00603109 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00603109 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00603109 about?
NCT00603109 is a clinical study titled "Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome". The purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1 blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects with Prader-Willi Syndrome (PWS). This will be a double blind placebo controlled clinical trial involving a total of ...
What is the current status of trial NCT00603109?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 10 participants. The study started on 2007-08. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00603109?
The interventions under investigation include: placebo (DRUG), rimonabant (DRUG).
Who is sponsoring clinical trial NCT00603109?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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