A Phase III, Non-inferiority, Double-blind, Unicenter Clinical Trial With Two Treatment Arms - Test Group With Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Latency to persistent sleep measured by polysomnography
研究概览
简要总结
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.
详细描述
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia. To that end, the latency to persistent sleep (LPS) will be used as a primary endpoint at the end of the treatment, measured by polysomnography.
The secondary objectives and endpoints of this study are as follows:
- To evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints:
- Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia (see Appendix A), namely:
- Latency time to the beginning of the sleep;
- Frequency of night wake-ups;
- Time awake during bedtime;
- Early morning awakening;
- Total time in bed;
- Sleep efficiency;
- Sleep variables measured by actigraph;
- Insomnia Severity Index (see Appendix B);45
- Pittsburgh Sleep Quality Index (see Appendix C);46
- To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.
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)
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
- •Sign the informed consent form for the study;
- •Be ≥ 20 to ≥ 64 years old;
- •Have diagnosis of symptomatic primary insomnia for at least 3 months;
- •Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes;
- •Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).
排除标准
- •Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study;
- •Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study;
- •Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study;
- •Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;
- •History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day);
- •History of substance abuse or dependence;
- •Patients with severe co-morbidities (at the investigator's opinion);
- •Presence of liver disorders, cirrhosis or liver failure;
- •Presence of psychiatric disorders diagnosed at the adult life or currently under treatment;
- •Pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.
研究组 & 干预措施
eszopiclone 3 mg
Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
干预措施: Eszopiclone (Drug)
zopiclone 7,5mg
Zopiclone once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
干预措施: Zopiclone (Drug)
结局指标
主要结局
Latency to persistent sleep measured by polysomnography
时间窗: 4 weeks
Determine whether eszopiclone is noninferior to the reference drug zopiclone (Imovane®) in the treatment of insomnia. The latency to persistent sleep will be used as a primary endpoint at the end of the treatment, measured by polysomnography
次要结局
- Efficiency using the variables latency time to persistent sleep, frequency of night awakenings, time awake during bedtime, early morning awakening, total time in bed, total time awake and sleep efficiency(6 weeks)