NCT00359229已完成4 期
A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 115
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI) score
研究概览
简要总结
Primary objective:
- To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China
Secondary objectives:
- To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China.
- To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary out-patient insomniac patient defined by DSM-IV criteria
- •Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours
排除标准
- •Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect
- •Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study.
- •Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs.
- •The score of Hamilton Depression Rating Scale (HAMD-24 ) more than
- •The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than
- •Patients having known hypersensitivity to Stilnox or any of the ingredients in the products
- •Patient with severe respiratory insufficiency
- •Patients suffering from sleep apnoea syndrome
- •Patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases
- •Patients suffering from severe myasthenia gravis
- •Patients with the previous history of drug abuse, drug dependence and drug addiction
- •Any other disease state or major psychiatric condition that might affect study result
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
For 3 weeks
干预措施: Zolpidem (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI) score
时间窗: At 1 week versus baseline
次要结局
- Pittsburgh Sleep Quality Index score(At 3 weeks versus baseline)
- Subject sleeping efficacy variable(At 1 week and 3 weeks versus baseline)
- Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score(At 3 weeks versus baseline)
- Adverse events (AE) and Serious adverse events (SAE) reports(Throughout the study period)
- General Lab tests including hepatic and renal function(At 3 weeks versus baseline)
- Vital signs(At 1 week and 3 weeks versus baseline)
研究者
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