NCT00432198已完成4 期
Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Mean daily sleep latency for double-blind period
研究概览
简要总结
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10
- •patients whose age at the time of obtaining consent is 12 years or over and 18 years or below
排除标准
- •patients with schizophrenia or manic-depressive illness
- •patients with insomnia caused by physical diseases
- •patients having a history of hypersensitivity to zolpidem
- •patients with attention-deficit hyperactivity disorder
研究组 & 干预措施
1
Experimental
Oral
干预措施: Zolpidem (Myslee®) (Drug)
2
Experimental
Oral
干预措施: Zolpidem (Myslee®) (Drug)
3
Placebo Comparator
Oral
干预措施: placebo (Drug)
结局指标
主要结局
Mean daily sleep latency for double-blind period
时间窗: 2 Weeks
次要结局
- Impression of patient for double-blind period(2 Weeks)
- Mean daily time of intermediate awaking(2 Weeks)
- Mean daily total hours of sleep(2 Weeks)
- Mean daily frequency of intermediate awaking(2 Weeks)
研究者
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