A Phase III, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects With Chronic Insomnia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Mean latency to persistent sleep of 2-night per polysomnogram recordings, from nights 1 and 2 of each Treatment Period.
研究概览
简要总结
This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.
详细描述
Insomnia is characterized by a complaint of difficulties initiating and maintaining sleep or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had .ever had difficulty sleeping. Based on reports of regular or frequent sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
Participation in this study is anticipated to be about 2 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ramelteon and Placebo QD (9 possible combinations total)
干预措施: Ramelteon and Placebo (9 possible combinations total) (Drug)
结局指标
主要结局
Mean latency to persistent sleep of 2-night per polysomnogram recordings, from nights 1 and 2 of each Treatment Period.
时间窗: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
次要结局
- Sleep Efficiency.(Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.)
- Wake Time after Sleep Onset.(Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.)
- Subjective Sleep Latency.(Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.)
- Subjective Sleep Quality.(Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.)
- Subjective Ease of Falling Back to Sleep after Awakening.(Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.)
- Subjective Total Sleep Time.(Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.)
- Subjective Number of Awakenings.(Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.)
- Total Sleep Time.(Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.)
- Number of Awakenings after Persistent Sleep Onset.(Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.)
- Subjective Wake Time after Sleep Onset.(Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.)