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NCT00459992 · ClinicalTrials.gov registry record · Phase 1
Effects of Betahistine Hydrochloride in Overweight Women
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
NCT00459992 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 150 participants.
The verdict
NCT00459992, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
Study Summary
This study will evaluate the effects of a drug called betahistine on appetite and food intake in overweight women. Betahistine has been used for many years to treat vertigo (dizziness). It was taken off the market in the United States in 1970 because it was thought to be ineffective for vertigo, but is still used for this purpose in many other countries. Some research suggests that betahistine may reduce appetite and food intake. Healthy overweight women between 18 and 50 years of age may be eligible for this study. Candidates must have a body mass index (BMI) between 30 and 40 and weigh less than 300 pounds. They are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), breathing test and eating behavior questionnaires. Participants are admitted to the NIH Clinical Center for a 3-day/2-night stay for the following procedures: * Medication: Subjects take either betahistine (in one of three possible doses) or placebo capsules one time on the days of admission to the Clinical Center (day 1), three times on day 2 and two times on day 3. * Blood tests and 24-hour urine collection. * Resting metabolic rate: Subjects rest quietly for 1 hour after awakening and then rest again under a clear plastic hood or while wearing a face mask, breathing normally for about 25 minutes. * DEXA scan to measure body fat, muscle, and bone mineral content: Subjects lie on a table above a source of X-rays while a very small dose of X-rays is passed through the body. * Meal studies: Subjects food intake is measured on days 2 and 3. * Questionnaires: Subjects complete questionnaires about how hungry or full they are feeling and rate how much they liked the foods they ate.
Interventions
- DRUG Betahistine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2007-04-10 |
| Est. Completion | 2011-02-14 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00459992
The ClinicalTrials.gov registry entry for NCT00459992 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Betahistine Hydrochloride is the first listed.
NCT00459992 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00459992 about?
NCT00459992 is a clinical study titled "Effects of Betahistine Hydrochloride in Overweight Women". This study will evaluate the effects of a drug called betahistine on appetite and food intake in overweight women. Betahistine has been used for many years to treat vertigo (dizziness). It was taken off the market in the United States in 1970 because it was thought to be ineffective for vertigo, but...
What is the current status of trial NCT00459992?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2007-04-10. Estimated completion is 2011-02-14.
What interventions are being tested in trial NCT00459992?
The interventions under investigation include: Betahistine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00459992?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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