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

Completed · Phase 3 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01888497

Run by

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

People needed

59

Starts

2013-07-29

Expected to finish

2013-12-14

Last updated by the study team

2021-02-21

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Baptist Sleep Centers, LLP — South Miami, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• NeuroTrials Research Sleep Lab — Atlanta, Georgia, United States
• NeuroTrials Research, Inc. — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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