drugset / Trial / NCT01888497
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
RandomizedCrossoverDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2013-07-29
- Primary completion
- 2013-12-14
- Completion
- 2013-12-14
Outcome
Missed primary endpoint
registry Placebo vs Diphenhydramine Citrate; p <0.001; Hodges-Lehman estimate 2.37 (95% CI 1.01 to 3.98) NCT01888497 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diphenhydramine | Small molecule | 76 mg | Oral |
| Subject | Gabapentin | Unknown | 250 mg | Oral |
| Comparator | Triazolam | Small molecule | 0.5 mg | Oral |
Indications
No indication recorded.