Phase II / III Study, One Center, Double-Blind, With Placebo Use, in Parallel Groups to Assess the Efficacy and Safety of Zolpidem® Orodispersible in Adult Subjects (Females and Males) in the Treatment of Maintenance Insomnia Disorder.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 366
- 主要终点
- Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment
研究概览
简要总结
Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.
详细描述
Information provided evidence for the therapeutic use of Zolpidem® in the treatment of insomnia. Several studies have emphasized the importance of using Zolpidem® in small doses, in the orodispersible form, in the treatment of insomnia. Accordingly, Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.
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
- Double (Participant, Investigator)
盲法说明
Placebo
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
- •Men and women ≥ 18 years and ≤ 64 years of age
- •Participants willing and able to provide a written informed consent form, after an explanation of the nature of the study, and prior to any procedures related to the study.
- •Adults with clinical diagnosis of insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V-TR) and who complain of difficulty in maintaining sleep, starting more than three months before the study initiation, and for three or more sleepless nights per week.
- •Participants with ability to understand and willingness to comply with the study procedures
排除标准
- •History of Allergy or Hypersensitivity to Zolpidem;
- •All initial and secondary insomnia;
- •Basal polysomnography with apnea and hypopnea index> 20 events / hour and PLM (Periodic Leg Movements)> 15 events / hour.
- •Participants who used central nervous system medication or other medication known to interfere with the sleep / wake up cycle within 15 days prior to enrollment in the study, at the discretion of the study investigator.
- •Clinically significant diseases or surgeries, at the discretion of the principal investigator, within 30 days prior to study inclusion.
- •History of chemical dependence or alcohol abuse.
- •Any significant neurological and psychiatric disease or laboratory findings present, unless adequately controlled with medication allowed in the protocol.
- •Participants who received any investigational medication in the last 12 months prior to study inclusion.
- •Women who are pregnant or breastfeeding or who wish to become pregnant or who refuse to use safe contraceptive methods during the study.
- •Any disorder of the circadian cycle.
- •Regular night shift work within the last 2 weeks prior to study enrollment or expected to work in shifts during the study.
研究组 & 干预措施
Men - Placebo
Men - Placebo, 1 tablet if a wake up occurs
干预措施: Zolpidem (Drug)
Men - Zolpidem 1.75 mg
Men - Zolpidem 1.75 mg, 1 tablet if a wake up occurs
干预措施: Zolpidem (Drug)
Men - Zolpidem 3.5 mg
Men - Zolpidem 3.5 mg, 1 tablet if a wake up occurs
干预措施: Zolpidem (Drug)
Women - Placebo
Women - Placebo, 1 tablet if a wake up occurs
干预措施: Zolpidem (Drug)
Women - Zolpidem 1.0 mg
Women - Zolpidem 1.0 mg, 1 tablet if a wake up occurs
干预措施: Zolpidem (Drug)
Women - Zolpidem 1.75 mg
Women - Zolpidem 1.75 mg, 1 tablet if a wake up occurs
干预措施: Zolpidem (Drug)
结局指标
主要结局
Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment
时间窗: 28 days
To analyse the efficacy of Zolpidem® Orodispersible treatment 1.0 mg or 1.75 mg in women and 1.75 mg and 3.5 mg in men, compared to placebo, after taking the medication when a spontaneous wake up occurs during 28 days. The assessement will be performed by means of the standard questionnaire before and at the end of the treatment period. The computed mean difference for each treatment will be compared by ANOVA (treatment doses vs placebo in each gender) in order to assess its statistical significance.
次要结局
- Sleep Efficiency (polysomnography parameter)(1 day)
- Sleep Latency (polysomnography parameter)(1 day)
- Total Sleep Time (polysomnography parameter)(1 day)