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OpenTrials
Completed

NCT Number: NCT00481975

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

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.

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Key information

Conditions

Obesity Body Weight Bulimia Eating Disorders Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rimonabant (SR141716)

Drug

Primary outcomes

  1. Change in body weight from baseline to Day 180 visit

Secondary outcomes

  1. Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index

  2. Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 4, 2007
Registry last updated
Apr 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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