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

Viatris logo

Viatris

Status and phase

Completed
Phase 3

Conditions

Healthy

Treatments

Drug: Gabapentin
Drug: Triazolam
Drug: Placebo
Drug: Diphenhydramine citrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01888497
A9451178

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy males and females of non-childbearing potential, 25-55 years of age
  • Valid driver's license

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

59 participants in 4 patient groups, including a placebo group

Arm A
Experimental group
Treatment:
Drug: Gabapentin
Arm B
Experimental group
Treatment:
Drug: Diphenhydramine citrate
Arm C
Active Comparator group
Treatment:
Drug: Triazolam
Arm D
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems