NCT00674752已完成3 期
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 377 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 377
- 试验地点
- 1
- 主要终点
- Wake after sleep onset as measured by polysomnography (PSG)
研究概览
简要总结
The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening
- •Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening
排除标准
- •Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
- •Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
研究组 & 干预措施
A
Experimental
干预措施: Gabapentin (Drug)
B
Experimental
干预措施: Gabapentin (Drug)
C
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Wake after sleep onset as measured by polysomnography (PSG)
时间窗: Hour +8
次要结局
- Adverse events(Hour +13)
- PSG Sleep Efficiency(Hour +8)
- PSG Wake Time During Sleep(Hour +8)
- PSG Sleep Onset Latency(Hour +8)
- PSG Latency to Persistent Sleep(Hour +8)
- PSG WASO(Hour +8)
- PSG Percent of Stages 1, 2, 3, 4 and REM sleep(Hour +8)
- subjective Wake After Sleep Onset (WASO)(Hour +8)
- subjective Assessment of Sleep Quality(Hour +8)
- Vital signs(Hour +8)
- PSG NA(Hour +8)
- subjective Assessment of Sleep Refreshment(Hour +8)
- Karolinska Sleep Diary-Sleep (KSD) Quality Index(Hour +8)
- PSG Total wake time plus Stage 1 sleep(Hour +8)
- subjective Sleep Latency(Hour +8)
- KSD individual scores(Hour +8)
- PSG TST(Hour +8)
- subjective Total Sleep Time (TST)(Hour +8)
- PSG Percent slow wave sleep (Stages 3&4 combined)(Hour +8)
- subjective Number of Awakenings (NA)(Hour +8)
研究者
研究点 (1)
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