NCT00883740已完成3 期
Effects Of Pregabalin On Sleep Maintenance In Subjects With Fibromyalgia Syndrome And Sleep Maintenance Disturbance: A Randomized Placebo-Controlled 2-Way Crossover Polysomnography Study
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 119 人开始时间: 2009年6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
- 119
- 试验地点
- 1
- 主要终点
- Wake After Sleep Onset (WASO) at Weeks 5 and 11
研究概览
简要总结
The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
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
- Double (Participant, Investigator)
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
- •Subjects must meet diagnostic criteria for fibromyalgia;
- •Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.
排除标准
- •History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
- •Use of medications known to affect sleep wake function by Visit 2;
- •Involved in night or rotating shift work, or travel across >4 time zones 14 days prior to screening and during study; regular daytime napping
- •PSG finding of apnea/hypopnea or periodic limb movement with arousal index >10/hr on either night of PSG.
研究组 & 干预措施
Lyrica
Experimental
flexible dosing Lyrica 300-450mg/day
干预措施: Pregabalin (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Wake After Sleep Onset (WASO) at Weeks 5 and 11
时间窗: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)
WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography \[PSG\]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording \[i.e. awake epoch immediately prior to the end of the recording\]) on 2 consecutive nights divided by 2 at the end of each intervention period.
次要结局
- Number of Awakenings After Sleep Onset (NAASO 2)(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- Wake Time During Sleep (WTDS)(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- Number of Awakenings After Sleep Onset (NAASO 1)(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- Sleep Quality(Weeks 1, 2, 3 and 4 of Each Intervention Period or ET)
- Daily Pain Score(Daily up to Day 73 or ET)
- Wake Time After Sleep (WTAS)(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- Sleep Efficiency (SE)(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- Latency to Persistent Sleep (LPS)(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- WASO by Hour of the Night(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- Total Sleep Time (TST)(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- WASO by Each Quarter of the Night(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- Slow Wave Sleep (SWS)(Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET)
- Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11(Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET)
- Latency of Sleep Onset (LSO)(Weeks 1, 2, 3 and 4 of Each Intervention Period or ET)
- Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11(Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET)
- Subjective Wake After Sleep Onset (sWASO)(Weeks 1, 2, 3 and 4 of Each Intervention Period or ET)
- Subjective Total Sleep Time (sTST)(Weeks 1, 2, 3 and 4 of Each Intervention Period or ET)
研究者
研究点 (1)
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