CTRI/2010/091/001177已完成3 期
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK4305 in Patients With Primary Insomnia- Study B
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Merck Co Inc
- 入组人数
- 945
- 试验地点
- 6
- 主要终点
- MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep
研究概览
简要总结
This is a multicenter study to test the hypothesis that MK4305 compared to placebo measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Globally 945 patients would be randomized in this trial. India would contribute up to 70 patients in this trial. Globally first patient was enrolled on 05 May 2010. At India, first patient screening is targated on 29 September 2010. Enrollment status: (globally) 1,019 patients and 27 patients (India)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Must be more than 18 yrs old on the day of signing informed consent Diagnosed with Primary Insomnia Patient is in good physical and mental health Patient more than and equal 65 yrs old score at least 25 on the Mini Mental State Exam A female patient who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception Patient reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria) Patient reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1 The patients regular bedtime is between 9 pm-1 am Patient is willing to refrain from napping while in study Patient is able to read, understand and complete questionnaires and all diaries Patient is willing to limit alcohol, caffeine, and nicotine consumption while in the study For a portion of patients: Patient must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory.
排除标准
- •Female patient is pregnant and or breastfeeding at Prestudy visit, or expecting to conceive while in study History or diagnosis of another sleep disorder Difficulty sleeping due to a medical condition History of a neurological disorder History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication Ongoing depression History of substance abuse or dependence History or current evidence of a clinically significant cardiovascular disorder or clinically significant ECG at Prestudy Visit Patient taking certain prohibited medications Patient consumes the equivalent of more than 15 cigarettes a day Patient has a history of malignancy less or equal 5 years prior to signing informed consent, with the exception of basal cell or squamous cell skin cancer if adequately treated Patient is considered morbidly obese Patient was previously randomized in another investigational study of MK4305.
结局指标
主要结局
MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep
时间窗: Month 1
次要结局
- MK4305 high dose versus placebo: Change from baseline in subjective total sleep time(Week 1)
- MK4305 high dose versus placebo: Change from baseline in wake time after persistent sleep onset(Night 1)
- MK4305 high dose versus placebo: Change from baseline in subjective time to sleep onset(Week 1)
- MK4305 high dose versus placebo: Change from baseline in latency to onset of persistent sleep(Night 1)
研究者
研究点 (6)
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