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Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica

NCT03179345 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-06-01

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Gabapentin

DRUG

Pregabalin

OTHER

Placebo

Sponsors & Collaborators

  • Depomed

    lead INDUSTRY

Principal Investigators

  • Head of R&D · Depomed

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-24
Primary Completion
2015-11-20
Completion
2015-11-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03179345 on ClinicalTrials.gov