NCT00956319已完成4 期
A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) in Patients With Primary 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
- 42
- 主要终点
- Total score of Pittsburgh Sleep Quality Index (PSQ)
研究概览
简要总结
The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary 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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
- •Written informed consent has been obtained
排除标准
- •Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
- •Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
- •Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
- •Patients who are pregnant, lactating or intend to become pregnant during the study period
- •Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
- •Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
- •Participation in any clinical trial within 1 month prior to randomization
研究组 & 干预措施
Zolpidem group
Experimental
干预措施: Zolpidem MR (Drug)
Estazolam group
Active Comparator
干预措施: Estazolam (Drug)
结局指标
主要结局
Total score of Pittsburgh Sleep Quality Index (PSQ)
时间窗: 3 weeks
次要结局
- Physician's clinical global impression (CGI)(3 weeks)
- Patient's global impression (PG)(3 weeks)
- Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary(3 weeks)
- Incidence and severity of adverse events, including abnormal sleep behavior(3 weeks)
研究者
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