MedTrace Logo

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

NCT01888497 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2021-02-21

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-29
Primary Completion
2013-12-14
Completion
2013-12-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01888497 on ClinicalTrials.gov