NCT00481975已完成3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 289
- 试验地点
- 7
- 主要终点
- Change in body weight from baseline to Day 180 visit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in body weight from baseline to Day 180 visit
次要结局
- 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
研究者
研究点 (7)
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