NCT00374777已完成3 期
FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Placebo- and Nitrazepam-Controlled, Group-Comparison Study in Patients With Insomnia Associated With Schizophrenia and Manic-Depressive Psychosis
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
- 450
- 主要终点
- Mean wake time after sleep onset during the double-blind period
研究概览
简要总结
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam 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
- •Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.
排除标准
- •Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.
研究组 & 干预措施
1
Experimental
干预措施: zolpidem MR (Drug)
2
Experimental
干预措施: zolpidem MR (Drug)
3
Active Comparator
干预措施: nitrazepam (Drug)
4
Placebo Comparator
干预措施: placebo (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
- Mean sleep latency during the double-blind period(2 Weeks)
- Patient impression during the double-blind period(2 Weeks)
- Mean total sleep time during the double-blind period(2 Weeks)
- Mean number of nightly awakenings during the double-blind period(2 Weeks)
研究者
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