A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Subjective Response to Treatment With Ramelteon in Adult Subjects With Chronic Insomnia by Utilizing an Interactive Voice Response System (IVRS) for Collecting Diary Data
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,081
- 主要终点
- Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.
研究概览
简要总结
The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults with chronic insomnia.
详细描述
Insomnia is characterized by difficulties initiating and maintaining sleep, or complaints of non-restorative 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 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 being conducted to assess the treatment effects of ramelteon in adults through the use of daily entry of information into an interactive voice response system. Study participation in this study is anticipated to be about 1 month.
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)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.
时间窗: Day 8
次要结局
- Electrocardiograms.(Day 15 or Final Visit.)
- Clinical Laboratory Tests Urinalysis(Day 15 or Final Visit.)
- Vital Signs.(Days 8 and 15 or Final Visit.)
- Mean Subjective Sleep Latency.(Day 15)
- Mean Subjective Total Sleep(Day 15)
- Adverse Events.(Days 1, 8, and 15 or Final Visit.)
- Clinical Laboratory Tests Hematology(Day 15 or Final Visit.)
- Clinical Laboratory Tests Chemistry.(Day 15 or Final Visit.)
- Physical Examinations.(Day 15 or Final Visit.)