NCT00283946已完成3 期
FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -
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
- 876
- 主要终点
- Mean wake time after sleep onset during the double-blind period
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of nonorganic insomnia.
- •Must be able to swallow tablets
排除标准
- •Allergic reactions to zolpidem (Myslee)
- •Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.
研究组 & 干预措施
1
Experimental
干预措施: Zolpidem MR (Drug)
2
Active Comparator
干预措施: Zolpidem (Drug)
结局指标
主要结局
Mean wake time after sleep onset during the double-blind period
时间窗: 2 Weeks
次要结局
- Safety(2 Weeks)
- Mean number of nightly awakenings during the double-blind period(2 Weeks)
- Mean total sleep time during the double-blind period(2 Weeks)
- Mean sleep latency during the double-blind period(2 Weeks)
- Patient impression during the double-blind period(2 Weeks)
研究者
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