A Randomised, Double-blind, Placebo-controlled Study to Determine the Long-term Efficacy and Safety of Ramelteon 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
- 451
- 主要终点
- Mean change in Latency to Persistent Sleep of 2-night polysomnogram.
研究概览
简要总结
The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
详细描述
A vast majority of people are affected by chronic insomnia in the western world. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.
An ideal treatment for chronic insomnia would include administration of therapy for an extended period. Specifically, it should be safe and effective for a period longer than the 7 to 10 days to which use of the current drugs approved for short-term use are limited.
Because of the absence of evidence of residual effects in pre-clinical studies and phase 2 and 3 clinical trials, ramelteon may be a candidate for extended use. As chronic insomnia becomes more prevalent, there is a need to assess the long-term efficacy and safety of nightly dosing with ramelteon in the general population. Study participation is anticipated to be about 8 months and 3 weeks.
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 —（Adult, 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 8 mg QD
干预措施: Ramelteon (Drug)
Placebo QD
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in Latency to Persistent Sleep of 2-night polysomnogram.
时间窗: Months 3 and 6 or Final Visit
次要结局
- Mean change in Subjective Sleep Latency by postsleep questionnaire on 2 nights over 6 months.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Mean change in Subjective Number of Awakenings by postsleep questionnaire.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Total Sleep Time in rapid eye movement (REM) sleep as determined by polysomnogram.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Total Sleep Time in stage 2 non-rapid eye movement (NREM) sleep as determined by polysomnogram.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Total Sleep Time in stage 3/4 non-rapid eye movement (NREM) sleep as determined by polysomnogram.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Total Sleep Time in stage 1 sleep as determined by polysomnogram.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Mean change in Subjective Total Sleep Time by postsleep questionnaire on 2 nights over 6 months.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Mean change in Total Sleep Time from polysomnogram, on 2 nights over 6 months.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Mean change in Subjective Sleep Quality by postsleep questionnaire.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Total Sleep Time in stage 1 non-rapid eye movement (NREM) sleep as determined by polysomnogram.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)
- Latency to Rapid Eye Movement as determined by polysomnogram.(Week 1 and Months 1, 3, 5 and 6 or Final Visit)