Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

Last updated: January 26, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

3

Condition

Neurologic Disorders

Pain

Treatment

N/A

Clinical Study ID

NCT01455415
A0081268
2011-002743-10
  • Ages > 18
  • All Genders

Study Summary

This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Type 1 or 2 diabetes with painful neuropathy
  • Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid paincondition with a regular dose
  • Meet pre-defined level of pain severity at entrance

Exclusion

Exclusion Criteria:

  • History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
  • Participated in a previous or ongoing pregabalin clinical trial
  • Neurologic disorders unrelated to diabetic neuropathy that may confound the assessmentof distal neuropathic pain

Study Design

Total Participants: 306
Study Start date:
December 01, 2011
Estimated Completion Date:
December 31, 2013

Connect with a study center

  • Klinika anesteziologie, resuscitace a intenzivni mediciny, 1.LF UK a VFN Fakultn�oliklinika

    Praha 2, 128 08
    Czech Republic

    Site Not Available

  • UNARS, s.r.o.

    Pelhrimov, 39301
    Czechia

    Site Not Available

  • Clintrial, s.r.o.

    Praha 10, 100 00
    Czechia

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Dipartimento di Medicina Interna e Specialit�ediche � DI.M.I.

    Genova, 16132
    Italy

    Site Not Available

  • U.O. Complessa di Diabetologia e Dietetica � ULSS 16

    Padova, 35143
    Italy

    Site Not Available

  • Fondazione PTV Policlinico Tor Vergata di Roma

    Roma, 00133
    Italy

    Site Not Available

  • Forskningsmottagningen Gamla Sjukhuset i Falkoping

    Falkoping, 521 43
    Sweden

    Site Not Available

  • Center for Lakemedelsstudier

    Malmo, 211 52
    Sweden

    Site Not Available

  • Citydiabetes

    Stockholm, 111 57
    Sweden

    Site Not Available

  • Dedicated Clinical Research

    Goodyear, Arizona 85395
    United States

    Site Not Available

  • Advanced Podiatry

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85023
    United States

    Site Not Available

  • Clinical Research Consortium

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Precision Trials

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • The Office of Joshua D. Holland, M.D.

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Genova Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Site Not Available

  • Center for United Research, Inc.

    Lakewood, California 90712
    United States

    Site Not Available

  • HealthCare Partners Medical Group

    Los Angeles, California 90015
    United States

    Site Not Available

  • IDS Pharmacy

    Los Angeles, California 90033
    United States

    Site Not Available

  • National Research Institute

    Los Angeles, California 90057
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Coastal Connecticut Research, LLC

    New London, Connecticut 06320
    United States

    Site Not Available

  • Neurological Group, PC

    New London, Connecticut 06320
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Meridien Research

    Bradenton, Florida 34208
    United States

    Site Not Available

  • Meridien Research

    Brooksville, Florida 34601
    United States

    Site Not Available

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • MD Clinical

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • AGA Clinical Trials

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Palm Beach Neurological Center,

    Palm Beach Gardens, Florida 33418
    United States

    Site Not Available

  • Meridien Research

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Meridien Research

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • Meridien Research

    Tampa, Florida 33606
    United States

    Site Not Available

  • Clinical Research of Central Florida

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Columbus Research Foundation

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Suburban Clinical Research

    Chicago, Illinois 60624
    United States

    Site Not Available

  • Suburban Clinical Research

    Naperville, Illinois 60564
    United States

    Site Not Available

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Arthritis and Diabetes Clinic, Inc.

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Miray Medical Center

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Genesis Clinical Research, LLC

    Fall River, Massachusetts 02720
    United States

    Site Not Available

  • Borgess Diabetes Center

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Borgess Research Institute

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Mercy Health Research

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Mercy Health Research

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Quality Clinical Research, Inc.

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Clinical Research Consortium

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Mirkil Medical Group

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • V.Jerome Mirkil, MD

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • The Medical Research Network, LLC

    New York, New York 10128
    United States

    Site Not Available

  • Davidson Medical Ministries

    Lexington, North Carolina 27292
    United States

    Site Not Available

  • Radiant Research (admin office)

    Cincinnati, Ohio 45249
    United States

    Site Not Available

  • Radiant Research

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Sooner Clinical Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • The Office of Veronique Sebastian, MD

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Sunstone Medical Research, LLC

    Medford, Oregon 97504
    United States

    Site Not Available

  • Blair Orthopedic Associates, Inc.

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Neurology and Pain Clinic, LLC

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • New Phase Research and Development

    Knoxville, Tennessee 37919
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

  • Centex Research, Inc.

    Houston, Texas 77062
    United States

    Site Not Available

  • Houston Neurocare

    Houston, Texas 77030
    United States

    Site Not Available

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