A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Adults With Chronic Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 848
- 主要终点
- Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind treatment.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in adult subjects with chronic insomnia.
详细描述
Insomnia is characterized by difficulties initiating and maintaining sleep or complaints 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, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
This study is designed to determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon, using subjective measures of sleep. Total subject participation time in this study is expected to be approximately 2 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（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 8 mg QD
干预措施: Ramelteon (Drug)
Ramelteon 16 mg QD
干预措施: Ramelteon (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind treatment.
时间窗: Weeks 1, 2, 3, 4, and 5 or Final Visit
次要结局
- Mean Subjective Sleep Latency per subject diary, over the week preceding the Day 15, Day 22, Day 29, and Day 36 Visits.(Weeks 2, 3, 4, and 5 or Final Visit)
- Subjective Total Sleep Time(Weeks 1, 2, 3, 4, and 5 or Final Visit)
- Subjective Number of Awakenings.(Weeks 1, 2, 3, 4, and 5 or Final Visit)
- Subjective Ease of Falling Back to Sleep after Awakening.(Weeks 1, 2, 3, 4, and 5 or Final Visit)
- Subjective Sleep Quality.(Weeks 1, 2, 3, 4, and 5 or Final Visit)
- Clinician's Clinical Global Impression(Weeks 1, 2, 3, 4, and 5 or Final Visit)