A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 830
- 主要终点
- Average of Subjective Sleep Latency
研究概览
简要总结
To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.
详细描述
This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled, multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve up to 9 visits and subject participation will be approximately 224 days. After meeting all screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
eszopiclone 3 mg tablet
干预措施: Eszopiclone (Drug)
2
Placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Average of Subjective Sleep Latency
时间窗: Days -14, 1, 30, 60, 90, 120, 150, 180
次要结局
- Average of Total Sleep Time (TST) and Wake Time After Sleep Onset (WASO)(Days -14, 1, 30, 60, 90, 120, 150, 180)
- SF-36(Days 1, 30, 90, 180)
- Work Limitations Questionnaire (WLQ)(Days 1, 30, 90, 180)
- Insomnia Severity Index (ISI)(Days 1, 30, 90, 180)
- Fatigue Severity Scale (FSS)(Days 1, 30, 90, 180)
- Epworth Sleepiness Scale (ESS)(Days 1, 30, 60, 90, 120, 150, 180)
- Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)(Day 180)
- Healthcare Utilization Questionnaire (HUQ)(Days 1, 30, 60, 90, 120, 150, 180)