At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 32 enrolled
Drug / intervention
Gabapentin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Double-Blind, Placebo-Controlled, Crossover Study Comparing Simulated Driving Performance, Daytime Sedation, and Cognition in Healthy Volunteers Taking Therapeutic Doses of Gralise®, Neurontin®, or Lyrica®
In Brief
A Phase 4 clinical trial evaluating Gabapentin, Pregabalin, and 1 other intervention for Healthy. Completed, enrolled 32 participants.
Detailed Summary
Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica® (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
Primary CompletionNov 2015
First PostedJun 2017
TodayJul 2026
First PostedJun 7, 2017
Enrollment StartSep 24, 2015
Primary CompletionNov 20, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.1 years ago
Interventions
Gabapentindrug
Pregabalindrug
Placeboother