MedTrace Logo

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

NCT01701362 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2021-01-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Neuropathic Pain

Interventions

DRUG

pregabalin

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

DRUG

placebo

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

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Croatia
  • Denmark
  • Germany
  • Hungary
  • Poland
  • Puerto Rico
  • Romania
  • South Africa
  • South Korea
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT01701362 on ClinicalTrials.gov