NCT05456152尚未招募3 期
National, Multicenter, Open, Single-arm, Phase III Clinical Trial to Evaluate the Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia.
EMS1 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2024年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Age between 18 to 64 years;
- •Participants diagnosed with chronic insomnia defined by difficulty in initiating or maintaining sleep in the last 3 months for at least 3 nights a week according to DSM-V criteria and confirmed by polysomnography;
- •Participants with difficulty in initiating or maintaining sleep parameters.
排除标准
- •Participants with clinical or laboratory diagnose of non-treated hypothyroidism or hyperthyroidism, kidney or liver failure;
- •Known hypersensitivity to any of the formula compounds;
- •Participants with other sleep disorders according to the International Classification Sleep Disorders (3rd edition), example: sleep-relate breathing disorders, circadian rhythm sleep-wake disorders, parasomnias (including history of sleep-walking after hypnotic use) and sleep related movement disorders;
- •Participants using sedatives or hypnotic medications;
- •Participants with current diagnosis of depression or anxiety according to the Diagnostic and Statistical Manual of Mental Disorders;
- •Participants with history of drug and alcohol abuse in the past 2 years;
- •Participants with current smoking habits during the night period;
- •Participants who treated insomnia in the last 3 months;
- •Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Participants with current or medical history of cancer in the last 5 years;
- •Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.
研究组 & 干预措施
Sublingual zolpidem
Experimental
1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.
干预措施: Sublingual Tablet (Drug)
结局指标
主要结局
To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment.
时间窗: 60 days.
The safety profile will be assessed considering the number and percentage of each adverse event.
次要结局
- To evaluate daytime sleepiness in the next morning.(60 days.)
- To assess the adverse events during 7 days after the last dose administration.(7 days.)
- To assess the number of adverse events in different periods of the clinical trial.(60 days.)
- To assess the number of participants with adverse events in different periods of the clinical trial.(60 days.)
研究者
研究点 (1)
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