NCT00366093已完成3 期
The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 410
- 主要终点
- mean subjective SL
研究概览
简要总结
To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.
详细描述
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of eszopiclone 3 mg in women with insomnia secondary to perimenopause or menopause. Eligible subjects will be randomized to either eszopiclone 3 mg or placebo nightly for four weeks. 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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 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
Experimental
eszopiclone 3 mg
干预措施: Eszopiclone (Drug)
2
Placebo Comparator
Placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
mean subjective SL
时间窗: Week 1
次要结局
- MADRS score(Week 4)
- Physician Global Assessment(Week 4)
- mean subjective WASO(Week 1)
- Mean subjective SL(Weeks 2, 3, 4)
- Mean subjective WASO(Weeks 2, 3, 4)
- Mean subjective TST(Weeks 1, 2, 3, 4)
- Mean number of awakenings(Weeks 1, 2, 3, 4)
- Sleep quality and depth(Weeks 1, 2, 3, and 4)
- Daytime alertness(Weeks 1, 2, 3, and 4)
- Ability to concentrate(Weeks 1, 2, 3, and 4)
- Physical well-being(Weeks 1, 2, 3, and 4)
- Ability to function(Weeks 1, 2, 3, and 4)
- Mean subjective number of nocturnal awakenings due to hot flashes(Weeks 1, 2, 3, and 4)
- Mean number of hot flashes per day(Weeks 1, 2, 3, and 4)
- Mean number of nocturnal hot flashes per night(Weeks 1, 2, 3, and 4)
- Mean severity of hot flashes(Weeks 1, 2, 3, and 4)
- ESS score(Weeks 2 and 4)
- ISI score(Weeks 2 and 4)
- GCS score(Weeks 2 and 4)
- SDS score(Week 4)
- MenQOL score(Week 4)
- withdrawal effects will be assessed for the ISI, ESS, MADRS, MenQOL, Greene Climacteric Scale, Sheehan Disability Scale, and Physician Global Assessment.(Week 5)
研究者
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