NCT00386334已完成4 期
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.
研究概览
简要总结
To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.
详细描述
A double-blind, randomized, placebo controlled, parallel group study of eszopiclone in elderly subjects with primary chronic insomnia. The study will involve up to 9 visits and subject participation will be approximately 18 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.
排除标准
- •Subject has recent history of known clinically significant abnormal laboratory findings.
研究组 & 干预措施
Placebo
Placebo Comparator
Week -2 to day 0 single blind one tablet placebo in the evening. Double blind period: Day 1 to Week 12 double blind one tablet placebo in the evening. Follow up period: two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.
干预措施: Placebo (Drug)
Eszopiclone
Experimental
Week -2 to day 0 single blind one tablet placebo in evening. Double Blind period: Day 1 to Week 12 double blind one tablet 2 mg of eszopiclone in evening. Follow up period consists of two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.
干预措施: Eszopiclone (Drug)
Eszopiclone
Experimental
Week -2 to day 0 single blind one tablet placebo in evening. Double Blind period: Day 1 to Week 12 double blind one tablet 2 mg of eszopiclone in evening. Follow up period consists of two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.
时间窗: Baseline (week 0), Day 1 (post first dose)-12 weeks
The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
次要结局
- Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.(Weeks 0, 3, 6, 9, 12, 14, 16)
- Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Subject-reported Daytime Alertness at Various Study Time Points.(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Subject-reported Ability to Function at Various Study Time Points(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.(Baseliine (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Subject-reported Ability to Concentrate at Various Study Time Points(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.(Weeks 0, 3, 6, 9, 12, 14, 16)
- Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - Week12)
- Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points(weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.(Baseline (week 0), Day 1 (post first dose) - Week12)
- Mean Subject-reported Sleep Latency Reported at Various Study Time Points.(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.(Baseline (week 0), Day 1 (post first dose) -week 12)
- Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.(Baseline (week 0), weeks 3,6,9,12,14,16)
- Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.(Baseline (week 0), Day 1 (post first dose) - Week12)
- Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Number of Awakenings (Subject-reported) at Various Study Time Points(Weeks 0,3,6,9,12,14,16)
- Mean Subject-reported Depth of Sleep at Various Study Time Points(weeks 0,3,6,9,12,14,16)
- Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Subject-reported Physical Well-Being at Various Study Time Points(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose)- week 12)
- Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.(Weeks 0,3,6,9,12,14,16)
- Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Subject-Reported Total Nap Time at Various Study Time Points(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points(Weeks 0,1,4,7,12,13,15)
- Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points(Baseline (week 0), Weeks 1,4,7,12,13,15)
- Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points(Baseline (week 0), Weeks 1,4,7,12,13,15)
- Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points(weeks 0,1,4,7,12,13,15)
- Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points(Baseline (week 0), Weeks 1,4,7,12,13,15)
- Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points(Baseline (week 0), Weeks 1,4,7,12,13,15)
- Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.(Weeks 0,1,4,7,12,13,15)
- Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points(Weeks 0,1,4,7,12,13,15)
- Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.(Baseline (week 0), Weeks 1,4,7,12,13,15)
- Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Mental Component Summary of the Short Form-36 Scale Scores(Weeks 0,6,12,16)
- Mean Change From Baseline in the Sheehan Disability Scale Total Score.(Baseline (week 0), Weeks 6,12,14,16)
- Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points(Week 0,1,4,7,12,13,15)
- Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points(Baseline (week 0), Weeks 1,4,7,12,13,15)
- Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.(Week 0,1,4,7,12,13,15)
- Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points(Baseline (week 0), Weeks 1,4,7,12,13,15)
- Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points(Week 0,1,4,7,12,13,15)
- Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period(Baseline (week 0), Day 1 (post first dose) - week 12)
- Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points(Baseline (week 0), Weeks 3,6,9,12,14,16)
- Mean Insomnia Severity Index Total Scores at Various Study Time Points(Weeks 0,3,6,9,12,14,16)
- Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale(Baseline (week 0), Weeks 6, 12, 16)
- Mean Physical Component Summary of the Short Form-36 Scale Scores.(Weeks 0,6,12,16)
- Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores(Baseline (week 0), Weeks 6,12,16)
- Mean Sheehan Disability Total Scores(Weeks 0,6,12,14,16)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary InsomniaPrimary InsomniaNCT00352144Sumitomo Pharma America, Inc.830
已完成
不适用
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia PatientsInsomniaNCT02455271Eisai Co., Ltd.438
已完成
3 期
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)InsomniaNCT00770692Eisai Co., Ltd.369
已完成
3 期
Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated InsomniaInsomniaAttention Deficit Hyperactivity DisorderNCT00857220Sumitomo Pharma America, Inc.304
已完成
4 期
Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP)Obstructive Sleep ApneaNCT00612157Walter Reed Army Medical Center154