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A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions

Description

Brief 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.


Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

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

  • 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 assessment of distal neuropathic pain

Sites

  • California

    • IDS Pharmacy, Los Angeles, California, 90033
    • HealthCare Partners Medical Group, Los Angeles, California, 90015
    • National Research Institute, Los Angeles, California, 90057
    • Center for United Research, Inc., Lakewood, California, 90712
    • Neuro-Pain Medical Center, Fresno, California, 93710
    • Diablo Clinical Research, Inc., Walnut Creek, California, 94598

  • Nevada

    • V.Jerome Mirkil, MD, Las Vegas, Nevada, 89119

  • Arizona

    • Dedicated Clinical Research, Goodyear, Arizona, 85395
    • The Office of Joshua D. Holland, M.D., Phoenix, Arizona, 85053
    • Arizona Research Center, Phoenix, Arizona, 85023
    • Clinical Research Consortium Arizona, Phoenix, Arizona, 85003
    • Clinical Research Consortium, Phoenix, Arizona, 85004
    • Precision Trials, Phoenix, Arizona, 85032
    • Advanced Podiatry, Phoenix, Arizona, 85032
    • Geneva Clinical Research, Tucson, Arizona, 85704

  • Oregon

    • Sunstone Medical Research, LLC, Medford, Oregon, 97504

  • Oklahoma

    • Sooner Clinical Research, Oklahoma City, Oklahoma, 73112
    • The Office of Veronique Sebastian, MD, Oklahoma City, Oklahoma, 73120

  • Texas

    • University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, 75390
    • Houston Neurocare, Houston, Texas, 77030
    • Centex Research, Inc., Houston, Texas, 77062
    • Centex Studies Inc. - Clear Lake Family Physicians (Admin Office), Houston, Texas, 77062

  • Nebraska

    • Quality Clinical Research, Inc., Omaha, Nebraska, 68114

  • Louisiana

    • Arthritis and Diabetes Clinic, Inc., Monroe, Louisiana, 71203

  • Missouri

    • Mercy Health Research, St. Louis, Missouri, 63141

  • Illinois

    • Suburban Clinical Research, Naperville, Illinois, 60564
    • Suburban Clinical Research, Chicago, Illinois, 60624

  • Michigan

    • Borgess Diabetes Center, Kalamazoo, Michigan, 49048

  • Kentucky

    • Central Kentucky Research Associates, Inc., Lexington, Kentucky, 40509

  • Georgia

    • Columbus Research Foundation, Columbus, Georgia, 31904

  • Czech Republic

    • UNARS, s.r.o., Pelhrimov, 39301
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