NCT01181232已完成4 期
A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary 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
- 132
- 主要终点
- Rest/activity cycles measured by Actigraphy
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.
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
- None
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
- •Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
- •Written informed consent has been obtained
排除标准
- •Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
- •Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
- •Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
- •Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
- •Patients who are pregnant, lactating or intend to become pregnant during the study period
- •Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
- •Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
- •Participation in any clinical trial within 1 month prior to randomization
研究组 & 干预措施
MR low-dose group
Experimental
干预措施: Zolpidem MR (Drug)
MR high-dose group
Experimental
干预措施: Zolpidem MR (Drug)
IR group
Active Comparator
干预措施: Zolpidem IR (Drug)
结局指标
主要结局
Rest/activity cycles measured by Actigraphy
时间窗: For 2 weeks (Day 0, Day 7, Day 14)
Total score of Pittsburgh Sleep Quality Index (PSQI)
时间窗: For 2 weeks (Day 0, Day 7, Day 14)
次要结局
- Sleep latency as derived from sleep diary(For 2 weeks (Day 0, Day 7, Day 14))
- Physician's clinical global impression (CGI)(For 2 weeks (Day 0, Day 7, Day 14))
- Day time function as assessed by Epworth Sleepiness Scale (ESS)(For 2 weeks (Day 0, Day 7, Day 14))
- Patient's global impression (PGI)(For 2 weeks (Day 0, Day 7, Day 14))
- Number of awakenings as derived from sleep diary(For 2 weeks (Day 0, Day 7, Day 14))
- Wake time after sleep onset as derived from sleep diary(For 2 weeks (Day 0, Day 7, Day 14))
- Total sleep time as derived from sleep diary(For 2 weeks (Day 0, Day 7, Day 14))
研究者
相似试验
已完成
4 期
A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia PatientsSleep Initiation and Maintenance DisordersPrimary InsomniaNCT00956319Astellas Pharma Inc42
已完成
3 期
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)Diabetes Mellitus, Type 2NCT00094757Merck Sharp & Dohme LLC521
已完成
4 期
An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With SchizophreniaSchizophreniaNCT00524043Johnson & Johnson Pharmaceutical Research & Development, L.L.C.201
已完成
3 期
A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.SchizophreniaNCT00086320Johnson & Johnson Pharmaceutical Research & Development, L.L.C.111
已完成
3 期
Study of Investigational Drug in Osteoporosis (MK-0217-908)Postmenopausal OsteoporosisNCT00092053Organon and Co203