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

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

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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