Phase 3
N=59
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01888497 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Standard Deviation of Lateral Position (SDLP) — 33.2; 34.2; 35.4; 47.4 centimeter (cm) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gabapentin (Drug); Diphenhydramine citrate (Drug); Triazolam (Drug); Placebo (Drug)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standard Deviation of Lateral Position (SDLP) |
33.2; 34.2; 35.4; 47.4 | <0.001 sig |
| SECONDARY Speed Deviation |
0.9; 0.9; 1.0; 1.3 | <0.001 sig |
| SECONDARY Lane Exceedance |
37.8; 46.7; 52.4; 147.7 | <0.001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01888497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.