NCT00163046已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 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 256 人开始时间: 2005年10月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
研究概览
简要总结
The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with 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
- •18 years of age or older with occasional sleeplessness in the month prior to screening
排除标准
- •Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
- •Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial
研究组 & 干预措施
Gabapentin
Experimental
干预措施: Gabapentin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
时间窗: Day 1
次要结局
- Adverse events(Through Day 32)
- PSG Total Wake Time (TWT) plus Stage 1 Sleep(Days 1 and 28)
- PSG Percent of Stages 1, 2, 3, 4 and REM sleep(Days 1 and 28)
- PSG WAPSO(Day 28)
- PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)(Days 1 and 28)
- Subjective SL(Days 1 and 28)
- Subjective ASQ(Days 1 and 28)
- Karolinska Sleep Diary (KSD)-Sleep Quality Index(Days 1 and 28)
- Subjective TST(Days 1 and 28)
- Subjective ASR(Days 1 and 28)
- Vital signs(Days 1 and 28)
- PSG Latency to Persistent Sleep (LPS)(Days 1 and 28)
- PSG Sleep Onset Latency (SOL)(Days 1 and 28)
- PSG Number of Awakenings (NAW)(Days 1 and 28)
- PSG Wake after Sleep Onset (WASO)(Days 1 and 28)
- PSG Sleep Efficiency (SE)(Days 1 and 28)
- Subjective WASO(Days 1 and 28)
- PSG Wake Time During Sleep (WTDS)(Days 1 and 28)
- PSG Total Sleep Time (TST)(Days 1 and 28)
- Subjective NA(Days 1 and 28)
- KSD individual scores(Days 1 and 28)
研究者
研究点 (1)
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