NCT00999219已完成3 期
FK199B (Zolpidem MR Tablet) Phase III Clinical Study - A Double-Blind, Crossover, Comparative Polysomnographic Study Using Zolpidem (Myslee®) as a Positive Control in Patients With Insomnia, Excluding Patients With Schizophrenia or 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
- 55
- 主要终点
- Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)
研究概览
简要总结
This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- •Patients complaining of insomnia continuously for 4 weeks or longer
- •Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening
- •Patient on most occasions sleeps for a total of ≥3 and <6.5 hours over the 4 week period prior to initial screening
- •Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening
- •Patients have a body weight of ≥45 kg and ≤85 kg, a BMI of ≥18.5 and <30
排除标准
- •Patients with schizophrenia or manic-depressive psychosis
- •Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic
- •Patients with circadian rhythm sleep disorder
- •Patient works night shifts
- •Patients with alcoholic sleep disorder
- •Patients with alcohol or drug dependence or a history of these
- •Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs
- •Patients with sleep apnea syndrome
- •Patients with restless legs syndrome or periodic limb movement disorder
- •Patients with epileptic insomnia
- •Patients smoke on average 40 or more cigarettes a day
- •Patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening
研究组 & 干预措施
Zolpidem-first group
Experimental
干预措施: Zolpidem (Drug)
FK199B-first group
Experimental
干预措施: FK199B (Drug)
FK199B-first group
Experimental
干预措施: Zolpidem (Drug)
Zolpidem-first group
Experimental
干预措施: FK199B (Drug)
结局指标
主要结局
Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)
时间窗: 8 hours
次要结局
- Sleep parameters estimated from sleep questionnaire(After each night of sleep during the study period)
- Mean sleep parameters estimated from polysomnography recording(8 hours)
- Patient impression from sleep questionnaire(After each night of sleep during the study period)
研究者
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