Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00481975

Purpose

The primary objective is to assess the effect of rimonabant compared to placebo on weight loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients with binge eating disorder.

The secondary objectives are:

to assess the effect of rimonabant on the number of binge episodes per week, to assess the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three Factor Eating Questionnaire (TFEQ),
to evaluate the safety and tolerability of rimonabant over a period of 6 months.

Condition	Intervention	Phase
Obesity Eating Disorders	Drug: rimonabant (SR141716)	Phase III

MedlinePlus related topics: Eating Disorders Obesity Weight Control

Drug Information available for: SR 141716A Rimonabant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Bind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study to Assess Efficacy and Safety of Rimonabant 20 mg Versus Placebo on Weight Loss and Frequency of Binge Episodes in Obese Patients With Food Craving

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change in body weight from baseline to Day 180 visit

Secondary Outcome Measures:

Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index
Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale

Enrollment:	289
Study Start Date:	August 2004
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Body Mass Index (BMI) ≥30 to ≤45 kg/m²
Diagnosis of eating disorder using The Questionnaire on Eating and Weight Patterns (QEWP-R) for diagnosing Eating Behaviors

Exclusion Criteria:

History of surgical procedures for weight loss
Treatment with anti-obesity drugs within 3 months prior to screening visit
Presence or history of Diagnostic and Statistical Manual of Mental Disorders (4th edition)(DSM IV) bulimia or anorexia nervosa

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481975

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	ACT3801
Study First Received:	June 1, 2007
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00481975 History of Changes
Health Authority:	United States: Food and Drug Administration; Finland: National Agency for Medicines; Switzerland: Swissmedic

Keywords provided by Sanofi-Aventis:

binge eating
eating disorders
obesity

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Mental Disorders
Bulimia

Weight Loss
Nutrition Disorders
Overweight
Overnutrition
Eating Disorders

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Mental Disorders

Nutrition Disorders
Overweight
Overnutrition
Eating Disorders

ClinicalTrials.gov processed this record on May 07, 2009