NCT00666939已完成3 期
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 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 773 人开始时间: 2004年10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
- 773
- 试验地点
- 1
- 主要终点
- Subjective sleep latency
研究概览
简要总结
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, 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
- •Aged >/= 18 years
- •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)
- •Recreational drug use within past 30 days
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
Subjective sleep latency
时间窗: Hour +8
次要结局
- Vital signs(Hour +8)
- Subjective number of awakenings(Hour +8)
- Subjective wake after sleep onset(Hour +8)
- Karolinska Sleep Diary-Sleep (KSD) Quality Index(Hour +8)
- Adverse events(Hour +13)
- Subjective assessment of sleep quality(Hour +8)
- Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)(Hour +8)
- Stanford Sleepiness Scale(Hour +13)
- Subjective total sleep time(Hour +8)
- Subjective assessment of sleep refreshment(Hour +8)
- KSD individual scores(Hour +8)
- Digit Symbol Substitution Test(Hour +8)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase AdvanceTransient InsomniaNCT00667108Pfizer's Upjohn has merged with Mylan to form Viatris Inc.784
已完成
3 期
A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase AdvanceTransient InsomniaNCT00666770Pfizer's Upjohn has merged with Mylan to form Viatris Inc.309
已完成
3 期
A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase AdvanceTransient InsomniaNCT00163046Pfizer's Upjohn has merged with Mylan to form Viatris Inc.256
已完成
3 期
A Polysomnographic Study Of Single-Dose Gabapentin In Transient InsomniaTransient InsomniaNCT00674752Pfizer's Upjohn has merged with Mylan to form Viatris Inc.377
已完成
3 期
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional SleeplessnessTransient InsomniaNCT00666575Pfizer's Upjohn has merged with Mylan to form Viatris Inc.2,105