Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with 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
- Double (Participant, Investigator)
盲法说明
Duble-blind and double-dummy
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 50 years or more;
- •Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
- •Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Known hypersensitivity to the formula components used during the clinical trial;
- •Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
- •History of hepatic impairment;
- •Current smoking;
- •Pregnancy or risk of pregnancy and lactating patients;
- •History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;
- •Diagnosis of clinical diseases that interfere with sleep;
- •Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;
- •Participation in clinical trial in the year prior to this study.
研究组 & 干预措施
HIPNOS 3
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day.
干预措施: Hipnos 3 (Drug)
HIPNOS 3
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day.
干预措施: Hipnos 5 Placebo (Other)
HIPNOS 5
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day.
干预措施: Hipnos 5 (Drug)
HIPNOS 5
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day.
干预措施: Hipnos 3 Placebo (Other)
HIPNOS Placebo
The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.
干预措施: Hipnos 5 Placebo (Other)
HIPNOS Placebo
The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.
干预措施: Hipnos 3 Placebo (Other)
结局指标
主要结局
Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.
时间窗: 4 weeks
次要结局
- Incidence and severity of adverse events recorded during the study.(5 weeks)