CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 542 enrolled
Drug / intervention
pregabalin +1 moredrug
Likely dose
pregabalin 600 mgfrom 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.

Search/NCT01701362
NCT01701362Phase 3Completed

A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Oct 5, 2012·Updated Jan 28, 2021

In Brief

A Phase 3 clinical trial evaluating pregabalin and placebo for Neuropathic Pain. Completed, enrolled 542 participants across 156 sites in 13 countries.

Detailed Summary

This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Canada, Croatia, Denmark, Germany, Hungary, Poland, Puerto Rico, Romania, South Africa, South Korea, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2012
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.7 years ago

Interventions

pregabalindrug

capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization

placebodrug

capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization