A 6-Month, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Outpatient Trial, Investigating the Efficacy and Safety of Org 50081 in Adult Patients With Chronic Primary Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 460
- 主要终点
- Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period
研究概览
简要总结
To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).
详细描述
Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.
The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on TST (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.
The current study is designed to assess the long-term efficacy and safety of esmirtazapine in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in participants suffering from chronic primary insomnia. During the 6-month treatment period, participants are randomly assigned to receive either esmirtazapine or placebo. Then, during the 7-day discontinuation period, participants who received esmirtazapine in the 6-month treatment period are randomly assigned to receive either esmirtazapine or placebo, while participants who received placebo in the 6-month treatment period continue to receive placebo.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are at least 18 and less than 65 years;
- •sign written informed consent after the scope and nature of the investigation have been explained;
- •have shown capability to complete the LogPad questionnaires;
- •have difficulty falling asleep, maintaining sleep or have early morning awakening;
排除标准
- •Significant medical or psychiatric illness causing sleep disturbances.
- •Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.
- •Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.
- •Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.
- •Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.
- •Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.
- •Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.
- •Routinely nap during the day.
- •Have a Body Mass Index (BMI) of 36 or more.
研究组 & 干预措施
Esmirtazapine 4.5 mg
Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months
干预措施: Esmirtazapine (Drug)
Placebo
Participants receive placebo tablets, administered once a day for 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period
时间窗: Baseline and the Mean of Weeks 14-26
TST was defined as the time recorded for sleep diary question 6 "How much time did you actually spend sleeping?" as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach.
次要结局
- Number of Participants Who Experienced Adverse Events (AEs)(Up to 31 weeks)
- Number of Participants Who Discontinued Study Drug Due to an AE(Up to 27 weeks)
- Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period(Baseline and the Mean of Weeks 14-26)
- Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period(Baseline and the Mean of Weeks 14-26)