NCT00748592撤回2 期
PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Wake After Sleep Onset (WASO) as determined by PSG assessment
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 month history of primary insomnia
- •Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
排除标准
- •Any history of psychiatric diagnosis
- •History or presence of any breathing related sleep disorder
- •History or presence of any medical or neurological condition that could interfere with sleep
- •Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PD 0200390, 5 mg
Experimental
干预措施: PD 0200390 (Drug)
PD 0200390, 15 mg
Experimental
干预措施: PD 0200390 (Drug)
PD 0200390, 30 mg
Experimental
干预措施: PD 0200390 (Drug)
结局指标
主要结局
Wake After Sleep Onset (WASO) as determined by PSG assessment
时间窗: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
次要结局
- Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)(Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24)
- Latency to persistent sleep (LPS) as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Latency to REM Sleep as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Sleep efficiency (SE) as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Number of awakenings after sleep onset (NAASO) as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Total sleep time (TST) as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Next day performance sa determined by Digit Symbol Substitution Test (DSST)(Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24)
- Total wake time (TWT) as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness(Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24)
- Number of arousals as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)(Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24)
- Wake time during sleep (WTDS) as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Wake time after sleep (WTAS) as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment(Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23)
- Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)(Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24)
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