Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Healthy |
| Intervention | Drug: Gabapentin Drug: Diphenhydramine citrate Drug: Triazolam Drug: Placebo |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Responsible Party | Pfizer |
| ClinicalTrials.gov Identifier | NCT01888497 |
| First Received | June 25, 2013 |
| Last Updated | April 2, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 25, 2013 |
|---|---|
| Last Updated Date | April 2, 2014 |
| Start Date | July 2013 |
| Estimated Primary Completion Date | December 2013 |
| Current Primary Outcome Measures | Standard Deviation of Lateral Position [Time Frame: 7.25 hours post dosing] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers |
|---|---|
| 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 |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Healthy |
| Intervention | Drug: Gabapentin 250 mg, oral, prior to bedtime on the night before performance testing Drug: Diphenhydramine citrate 76 mg, oral, prior to bedtime on the night before performance testing Drug: Triazolam 0.5 mg, oral, prior to bedtime on the night before performance testing Drug: Placebo Oral, prior to bedtime on the night before performance testing |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 59 |
| Estimated Completion Date | December 2013 |
| Estimated Primary Completion Date | December 2013 |
| 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 |
| Gender | Both |
| Ages | 25 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01888497 |
|---|---|
| Other Study ID Numbers | A9451178 |
| Has Data Monitoring Committee | No |
| Information Provided By | Pfizer |
| Study Sponsor | Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Baptist Sleep Centers, LLP | South Miami, Florida, United States, 33143 |
|---|---|
| Miami Research Associates | South Miami, Florida, United States, 33143 |
| NeuroTrials Research Sleep Lab | Atlanta, Georgia, United States, 30342 |
| NeuroTrials Research, Inc. | Atlanta, Georgia, United States, 30342 |