Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Randomized Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, B-2650
        • Pfizer Investigational Site
      • Eeklo, Belgium, B-9900
        • Pfizer Investigational Site
      • Genk, Belgium, B-3600
        • Pfizer Investigational Site
      • Pellenberg, Belgium, B-3212
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2E8
        • Pfizer Investigational Site
    • Ontario
      • Hawkesbury, Ontario, Canada, K6A 1A1
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 4V2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Pfizer Investigational Site
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3A 2B4
        • Pfizer Investigational Site
  • Germany
      • Bremen, Germany, 28329
        • Pfizer Investigational Site
      • Eichstaett, Germany, 85072
        • Pfizer Investigational Site
      • Goeppingen, Germany, 73033
        • Pfizer Investigational Site
      • Kiel, Germany, 24105
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
      • Nuernberg, Germany, 90489
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65189
        • Pfizer Investigational Site
  • Italy
      • Imperia, Italy, 18100
        • Pfizer Investigational Site
      • Milano, Italy, 20100
        • Pfizer Investigational Site
      • Napoli, Italy, 80126
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Roma, Italy, 00168
        • Pfizer Investigational Site
    • Pavia
      • Localita' Cravino, Pavia, Italy, 27100
        • Pfizer Investigational Site
  • Spain
      • Granada, Spain, 18014
        • Pfizer Investigational Site
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
      • Sevilla, Spain, 41071
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 400 10
        • Pfizer Investigational Site
      • Lidingo, Sweden, 181 39
        • Pfizer Investigational Site
      • Linkoping, Sweden, 581 85
        • Pfizer Investigational Site
      • Lulea, Sweden, 972 33
        • Pfizer Investigational Site
      • Skelleftea, Sweden, 931 87
        • Pfizer Investigational Site
      • Stockholm, Sweden, 182 88
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34390
        • Pfizer Investigational Site
    • Izmir
      • Inciralti, Izmir, Turkey, 35340
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
    • Florida
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • Missouri
      • Independence, Missouri, United States, 64055
        • Pfizer Investigational Site
    • New York
      • Rochester, New York, United States, 14621
        • Pfizer Investigational Site
      • Valley Stream, New York, United States, 11580
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Pfizer Investigational Site
      • Allentown, Pennsylvania, United States, 18013
        • Pfizer Investigational Site
      • Bethlehem, Pennsylvania, United States, 18017
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation.
  • Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks.

Exclusion Criteria:

  • Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy.
  • Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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