NCT01896336已完成4 期
National Study, Phase IV, Single-center, Double-blind, Randomized, Parallel, Controlled by 10 mg Oral Zolpidem, in Evaluating the Efficacy and Safety of Zolpidem 5 mg Sublingual in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
EMS1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2013年2月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Efficacy will be measured by sleep induction and maintenance.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.
详细描述
- National study, phase IV, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral.
- Experiment duration: 93 days.
- 05 visits (days -3, 0, 15, 45 and 90).
- Efficacy will be evaluated for: Sleep induction and the maintenance of sleep.
- Adverse events evaluation.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged between 20 and 64 years;
- •Diagnosis of primary insomnia according to criteria defined by DSM-IV;
- •Difficulty in maintaining sleep and waking up until 3 am;
- •Not having used any psychoactive drug in the last 30 days prior to their inclusion in the study;
- •Signature of IC.
排除标准
- •Previous history of serious medical illness, neurological or psychiatric disorder;
- •Allergy or hypersensitivity to zolpidem;
- •Obstructive Sleep Apnea syndrome;
- •Polysomnography with apnea and hypopnea index >10/hour or PLM >15/h;
- •Other secondary sleep disorders;
- •History of substance abuse or dependence;
- •History of daily consumption of alcoholic beverages;
- •Pregnancy, lactation or refusal to use safe contraceptive methods during the study.
研究组 & 干预措施
5mg sublingual Zolpidem hemitartrate
Experimental
1 QD
干预措施: Zolpidem Hemitartrate (Drug)
10 mg oral Zolpidem hemitartrate
Active Comparator
1 QD.
干预措施: Zolpidem Hemitartrate (Drug)
结局指标
主要结局
Efficacy will be measured by sleep induction and maintenance.
时间窗: 90 days
Sleep induction is measured by time to sleep after administration of the investigational product. The maintenance will be measured by the use of medication in the middle of the night and also by the elapsed time to sleep after administration of the investigational drug.
次要结局
- Safety will be evaluated by the adverse events occurrences(90 days)
研究者
研究点 (1)
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