A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CROSS-OVER, PLACEBO-CONTROLLED, SINGLE DOSE, CLINICAL TRIAL TO ASSESS THE NEXT-DAY RESIDUAL EFFECTS OF GABAPENTIN, DIPHENHYDRAMINE AND TRIAZOLAM ON SIMULATED DRIVING PERFORMANCE IN NORMAL VOLUNTEERS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Standard Deviation of Lateral Position (SDLP)
研究概览
简要总结
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal volunteer subjects. It will also examine other measures of next-day performance and next-day sleepiness.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females of non-childbearing potential, 25-55 years of age
- •Valid driver's license
排除标准
- •Psychiatric disorder
- •Recent history of clinically significant neurological disorder, such as seizures, stroke, multiple sclerosis, or head trauma
- •Recent histroy or current treatment for sleep disorder
研究组 & 干预措施
Arm A
干预措施: Gabapentin (Drug)
Arm B
干预措施: Diphenhydramine citrate (Drug)
Arm C
干预措施: Triazolam (Drug)
Arm D
干预措施: Placebo (Drug)
结局指标
主要结局
Standard Deviation of Lateral Position (SDLP)
时间窗: 7.25 hours post-dose
Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). SDLP was used to assess driver's ability to track their lane and was the standard deviation of lane positions through the entire drive.
次要结局
- Lane Exceedance(7.25 hours post-dose)
- Speed Deviation(7.25 hours post dose)