Efficacy and Safety of SR46349B (1 and 5mg/Day) Administered During 8 Weeks in Patients With Sleep Disorders in Fibromyalgia: Multi-center, Randomized, Double-blind, Placebo-controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 205
- 试验地点
- 12
- 主要终点
- refreshing quality of sleep measured by the patient sleep questionnaire
研究概览
简要总结
Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. By improving the quality of sleep, complaints of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this chronic pain disorder may be improved.
详细描述
The purpose of this research study is to investigate the effectiveness and safety of 2 doses of the investigational product in subjects with sleep disorders with fibromyalgia as compared to placebo (a substance which contains no active ingredient). The study will last approximately 70 days and will include 7 office visits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient must fulfill the diagnosis criteria of fibromyalgia according to the American College of Rheumatology
- •Based on patient's information:
- •The patient must complain of unrefreshing sleep for at least 3 nights per week over the past month.
- •The patient spends at least 6.5 hours and not more than 9 hours, in bed, each night over the past 2 weeks.
- •Female patients of childbearing potential must have a confirmed negative pregnancy test at the end of the screening period and use an acceptable method of birth control throughout the study
- •Written, signed and dated informed consent must be obtained from each patient
- •Willing to abstain from taking any medication or treatment prohibited as per the protocol
排除标准
- •Females who are lactating or pregnant
- •Night shift workers, and individuals who nap 3 or more times per week over the preceding month (nap: intentionally sleeping for more than 20 minutes during the day).
- •Consumption of beverage with caffeine (i.e. tea, coffee, or cola) comprising more than 2 cups or glasses per day
- •Past or Current medical history of any significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
研究组 & 干预措施
1
1 mg daily
干预措施: eplivanserin (SR46349) (Drug)
2
5 mg daily
干预措施: eplivanserin (SR46349) (Drug)
3
干预措施: placebo (Drug)
结局指标
主要结局
refreshing quality of sleep measured by the patient sleep questionnaire
时间窗: 8 weeks
次要结局
- sleep parameters (maintenance, duration, induction and quality)(8 weeks)