NCT01888497

Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Gabapentin	250 mg, oral, prior to bedtime on the night before performance testing
DRUG	Diphenhydramine citrate	76 mg, oral, prior to bedtime on the night before performance testing
DRUG	Triazolam	0.5 mg, oral, prior to bedtime on the night before performance testing
DRUG	Placebo	Oral, prior to bedtime on the night before performance testing

Timeline

• Start date: 2013-07-29
• Primary completion: 2013-12-14
• Completion: 2013-12-14
• First posted: 2013-06-27
• Last updated: 2021-02-21
• Results posted: 2021-02-05

Locations

4 sites across 1 country: United States