NCT00283790已完成4 期
Investigation of Psycliomotor and Cognitive Residual Effects After Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopielone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Plurazepam 30 mg As An External Comparator
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Psychometric testing:
研究概览
简要总结
Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Flurazepam 30 mg as an External Comparator
详细描述
This is a crossover study, with 4 different treatments (Ambien, Lunesta, placebo, and flurazepam). The flurazepam arm always comes last due to the long washout period associated with it. The other 3 arms are randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged between 18 and 45 years.
- •Usual bedtime between 21:00 and 01:00
- •Body mass index (BMI) between 18 and 32 kg/m
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and a complete physical examination).
- •Laboratory tests within the normal range of the laboratory (hematology, biochemistry, urinalysis) or within the acceptable range per agreement between investigator and sponsor.
- •Negative urine pregnancy test for females (to be confirmed at screening and prior to every dose of study medication)
- •Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or they must be surgically sterilized or post-menopausal. If abstinent, women must agree to use double-barrier contraception throughout the study period should they become sexually active.
- •Written informed consent signed
排除标准
- •Presence or history of clinically relevant cardiovascular, hepatic, pulmonary, gastrointestinal, renal, metabolic, hematological, neurologic or psychiatric disease, any acute infectious disease or signs of acute illness, and myasthenia gravis
- •Any disorder initiating or maintaining sleep such as Obstructive Sleep Apnea, Insomnia, Restless Leg Syndrome, Periodic Limb Movement Disorder, Circadian Rhythm Disorder and Parasomnia
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- •Symptomatic hypotension, whatever the decrease of blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
- •History of hypersensitivity to zolpidem, eszopiclone, or flurazepam.
- •Use of any medication within one month prior to study start, except occasional use of acetaminophen or ibuprofen.
- •History of drug abuse during prior twelve months
- •Excessive consumption of xanthine-based beverages (more than 6 cups or glasses per day) or unable to stop consumption during the overnight study periods.
- •Inability to communicate or cooperate with the investigator because of a language problem, poor mental status, or impaired cerebral status.
- •Positive results of urine drug screen testing (amphetamines, benzodiazepines, cannabis, barbiturates, cocaine, opiates, antidepressants).
- •Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins)
- •Current use of tobacco products including cigarettes, cigars, pipes, or chewing tobacco, current participation in a smoking cessation program, or discontinuation of smoking within 3 months prior to screening
- •Subject is currently participating in another clinical trial with an investigation product/device (or within 30 days of screening).
结局指标
主要结局
Psychometric testing:
Critical Flicker Fusion (CFF)
Choice Reaction Time (CRT)
Immediate and Delayed Recall of Supraspan Word Lists (WRI and WRD)
Compensatory Tracking Task (CTT)
Digit Symbol Substitution Test (DSST)
次要结局
- Efficacy Measures:
- Sleep measures from Morning Sleep Questionnaire
- Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
- Leeds Sleep Evaluation Questionnaire (LSEQ)
- Bond & Lader (B&L) Visual Analog Scale
- Health Outcome Measures
- Sleep Treatment Questionnaire
研究者
研究点 (2)
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