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NCT01888497 · ClinicalTrials.gov registry record · Phase 3
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 59
- Enrollment target
NCT01888497: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01888497 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 59 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01888497, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 59 participants
- Enrollment target
Study 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.
Primary Outcome
Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). SDLP was used to assess driver's ability to track their lane and was the standard deviation of lane positions through the entire drive.
Interventions
- DRUG Placebo
- DRUG Gabapentin
- DRUG Triazolam
- DRUG Diphenhydramine citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2013-07-29 |
| Est. Completion | 2013-12-14 |
| Phase | Phase 3 |
What the finished NCT01888497 record still lists
NCT01888497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01888497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01888497 about?
NCT01888497 is a clinical study titled "Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers". 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 perform...
What is the current status of trial NCT01888497?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2013-07-29. Estimated completion is 2013-12-14.
What interventions are being tested in trial NCT01888497?
The interventions under investigation include: Placebo (DRUG), Gabapentin (DRUG), Triazolam (DRUG), Diphenhydramine citrate (DRUG).
Who is sponsoring clinical trial NCT01888497?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01888497's enrollment target sits among peer trials
59 1824th of 2000 higher than 176 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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