NCT02455271已完成不适用
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 438
- 主要终点
- Assessment of overall improvement
研究概览
简要总结
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed LUN01S and need to continue eszopiclone
排除标准
- 未提供
研究组 & 干预措施
Participants with insomnia
Participants with insomnia who will receive eszopiclone per approved label.
干预措施: Eszopiclone (Drug)
结局指标
主要结局
Assessment of overall improvement
时间窗: At month 6
Participants will be interviewed regarding sleep improvement at 6 months after first dose or discontinuation, relative to predose, and select the appropriate answer: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
次要结局
- Number of participants with adverse events (AEs)(Up to 6 months)
研究者
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