Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients

Phase 3CompletedNCT00481975

Sanofi289 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

289

Conditions

Obesity Eating Disorders

Interventions

rimonabant (SR141716)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (7)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Helsinki, Finland

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Gouda, Netherlands

Outcomes

Primary Outcomes

Change in body weight from baseline to Day 180 visit

Secondary Outcomes

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

Data from ClinicalTrials.gov

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