Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Gabapentin (Drug); Diphenhydramine citrate (Drug); Triazolam (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A Phase 3 Randomized, Double-blind, Cross-over, Placebo-controlled, Multi-center, Single-dose, Clinical Trial to Assess the Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Standard Deviation of Lateral Position
Secondary outcome: Speed DeviationLane Exceedances
Eligibility
Minimum age: 25 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Baptist Sleep Centers, LLP, South Miami, Florida 33143, United States
Miami Research Associates, South Miami, Florida 33143, United States
NeuroTrials Research Sleep Lab, Atlanta, Georgia 30342, United States
NeuroTrials Research, Inc., Atlanta, Georgia 30342, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: July 2013
Last updated: December 15, 2014
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