NCT01196650已完成2 期
A Double Blind, Polysomnographic, Three-Way Crossover Study to Compare the Efficacy of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Wake after sleep onset
研究概览
简要总结
This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between the ages of 18 and 65 years of age
- •Subjects that meet DSM IV diagnostic criteria for Insomnia
- •Subjects that report a time in bed NLT 6.5 and NMT 9 hours
- •Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
- •Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep >1.0 hour
- •Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset
- •On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
- •On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
- •On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights
排除标准
- •Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
- •Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
- •Subject with a history (past year) of alcohol or substance abuse
- •Subject that needs to smoke during the sleep period time
- •Subject that reports habitual napping (more than 3 times per week)
研究组 & 干预措施
1
Active Comparator
IN 10 003 formulation A
干预措施: IN 10 003 formulation A (Drug)
2
Active Comparator
IN 10 003 formulation B
干预措施: IN 10 003 formulation B (Drug)
3
Placebo Comparator
Placebo capsules
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Wake after sleep onset
To determine the effect of IN 10 003 on Wake time After Sleep Onset (WASO) as the change from baseline for the mean of night 1 and 2 relative to placebo
次要结局
- Objective and Subjective sleep parameters
研究者
研究点 (3)
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