A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 369
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
详细描述
This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.
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
- 20 Years 至 84 Years（Adult, Older 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
Eszopiclone 1 mg- Elderly
干预措施: Eszopiclone 1 mg- Elderly (Drug)
Eszopiclone 2 mg- Elderly
干预措施: Eszopiclone 2 mg- Elderly (Drug)
Eszopiclone 2 mg- Non-elderly
干预措施: Eszopiclone 2 mg- Non-elderly (Drug)
Eszopiclone 3 mg- Non-elderly
干预措施: Eszopiclone 3 mg- Non-elderly (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: Up to 25 weeks (24 weeks treatment period & 1 week follow-up)
Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)\*100. An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.
次要结局
- Mean Change From Baseline In Sleep Latency(Baseline (screening period) and 4 weeks of treatment)
- Mean Change From Baseline in Wake Time After Sleep Onset (WASO)(Baseline (screening period) and 4 weeks of treatment)
- Mean Change From Baseline in Total Sleep Time(Baseline (screening period) and 4 weeks of treatment)
- Mean Change From Baseline in Total Number of Awakenings(Baseline (screening period) and 4 weeks of treatment)