Comparison of the Safety and Efficacy of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week,Randomized, Double-blind, Comparative, Parallel-group Study.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire
研究概览
简要总结
The primary objective is to compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.
Secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-patients with Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
排除标准
- •Based on patient's information, the patient has spent less than 6.5 hours or more than 9.0 hours, in bed, each night, over the preceding two weeks
- •Based on patient's information, the patient complains of less than one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
- •Disturbances of sleep maintenance parameters based on the patient's sleep questionnaire during the run-in period differing from pre-defined criteria.
- •Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
- •Night shift workers and individuals who nap 3 or more times per week
- •Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
干预措施: Volinanserin (M100907) (Drug)
2
干预措施: Lormetazepam (Drug)
结局指标
主要结局
Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire
时间窗: 4 weeks
次要结局
- Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire)(4 weeks)
- Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period(4 weeks)
- Subjective sleep parameters(4 weeks)