CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 150 enrolled
Drug / intervention
Betahistine Hydrochloridedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00459992
NCT00459992Phase 1Completed

Pilot Study of the Metabolic Effects of Betahistine Hydrochloride in Overweight Women

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Apr 13, 2007·Updated Dec 16, 2019

In Brief

A Phase 1 clinical trial evaluating Betahistine Hydrochloride for Obesity and 2 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 13, 2007
Enrollment StartApr 10, 2007
Primary CompletionFeb 14, 2011
TodayJul 1, 2026
Enrollment to primary: 3.8 yearsPosted 19.2 years ago

Interventions

Betahistine Hydrochloridedrug