CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 59 enrolled
Drug / intervention
Gabapentin +3 moredrug
Likely dose
Gabapentin 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01888497
NCT01888497Phase 3Completed
CompareCT.gov

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jun 27, 2013·Updated Feb 21, 2021

In Brief

A Phase 3 clinical trial evaluating Gabapentin, Diphenhydramine citrate, and 2 other interventions for Healthy. Completed, enrolled 59 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 27, 2013
Enrollment StartJul 29, 2013
Primary CompletionDec 14, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.0 years ago

Interventions

Gabapentindrug

250 mg, oral, prior to bedtime on the night before performance testing

Diphenhydramine citratedrug

76 mg, oral, prior to bedtime on the night before performance testing

Triazolamdrug

0.5 mg, oral, prior to bedtime on the night before performance testing

Placebodrug

Oral, prior to bedtime on the night before performance testing