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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

Description

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

  • Subjects must have chronic peripheral neuropathic pain present for than 6 months after 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.
  • Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms.
  • Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.

  • Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or with Complex Regional Pain Syndrome (CRPS, Type I or Type II).
  • Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
  • Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening.
  • Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction [heart attack] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism.
  • Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder (GAD) or major depression that is clinically stable.
  • Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
  • Use of prohibited medications in the absence of appropriate washout periods.

Sites

  • California

    • University of Southern California Keck School of Medicine, Los Angeles, California, 90033
    • Behavioral Research Specialists, LLC, Glendale, California, 91206
    • Behavioral Research Specialist, LLC, Glendale, California, 91206
    • Center for United Research, Inc., Lakewood, California, 90805
    • Center For United Research, Inc., Lakewood, California, 90805
    • Advanced Rx Clinical Research, Artesia, California, 90701
    • University of California, Irvine, Irvine, California, 92697
    • University Of California, Irvine, Irvine, California, 92697
    • NervePro Medical Corp., Irvine, California, 92618
    • Alliance Research Centers, South Orange County Surgical Medical Group, Laguna Hills, California, 92653
    • Alliance Research Centers, Laguna Hills, California, 92653
    • Elite Clinical Trials, Inc., Wildomar, California, 92595
    • Elite Clinical Trials, Wildmoar, California, 92595
    • North County Clinical Research, Oceanside, California, 92056
    • Samaritan Center for Medical Research, Los Gatos, California, 95032
    • Samaritan Center for Medical Research, Los Gatos, California, 95032
    • Diablo Clinical Research Inc., Walnut Creek, California, 94598
    • Northern California Research, Sacramento, California, 95821
    • Allied Clinical Research, Roseville, California, 95661

  • Nevada

    • Advanced Biomedical Research of America, Las Vegas, Nevada, 89123

  • Arizona

    • Dedicated Clinical Research, Goodyear, Arizona, 85395
    • The Pain Center of Arizona, Phoenix, Arizona, 85027
    • Arizona Research Center, Phoenix, Arizona, 85023
    • Neuromuscular Research Center, Phoenix, Arizona, 85028
    • HOPE Research Institute, Phoenix, Arizona, 85018
    • The Pain Center of Arizona, Phoenix, Arizona, 85018
    • Elite Clinical Studies, LLC, Phoenix, Arizona, 85018
    • Arizona Pain Specialist, PLLC, Scottdale, Arizona, 85258
    • Arizona Pain Specialists, PLLC, Scottsdale, Arizona, 85258
    • Quality of Life Medical & Research Centers, LLC, Tucson, Arizona, 85712
    • Advanced Clinical Therapeutics-LLC-Member of ARC [Urology], Tucson, Arizona, 85712

  • Utah

    • J. Lewis Research, Incorporated/Foothill Family Clinic South, Salt Lake City, Utah, 84121
    • J. Lewish Research, Inc./Foothill Family Clinic South, Salt Lake City, Utah, 84121
    • Lifetree Clinical Research, LC, Salt Lake City, Utah, 84106
    • J. Lewis Research, Inc./Foothill Family Clinic, Salt Lake City, Utah, 84109
    • J. Lewis Research Inc.-Foothill Family Clinic, Salt Lake City, Utah, 84109

  • Colorado

    • Colorado Clinic, Boulder, Colorado, 80301
    • Mountain View Clinical Research Inc., Denver, Colorado, 80209
    • St. Luke's Medical Clinic, Fort Collins, Colorado, 80525
    • Saint Luke's Medical Clinic, Fort Collins, Colorado, 80525

  • Oregon

    • Summit Research Network Inc., Portland, Oregon, 97210

  • Washington

    • Northwest Clinical Research Center, Bellevue, Washington, 98007
    • Summit Research Network (Seattle) LLC, Seattle, Washington, 98104
    • Washington Center for Pain Management, Edmonds, Washington, 98026

  • Texas

    • Grayline Clinical Drug Trials, Wichita Falls, Texas, 76309
    • DCT - Stone Oak, LLC dba Discovery Clinical Trials, San Antonio, Texas, 78258
    • The Medical Group Of Texas, Fort Worth, Texas, 76104
    • The Medical Group Of Texas, Ft Worth, Texas, 76104
    • Dallas Pain Consultants, Dallas, Texas, 75203
    • ClinRx Research, LLC, Richardson, Texas, 75080
    • Futuresearch Trials of Dallas, Dallas, Texas, 75231
    • Sealy Urgent Care Center and Medical Clinic, Sealy, Texas, 77474
    • Medstar Clinical Research Associates, Houston, Texas, 77083
    • Medstar Clinical ResearchMedstar Clinical Research, Houston, Texas, 77083
    • Agadadash Kuliev, MD, PA, Houston, Texas, 77043
    • Biopharma Informatic Inc. Research Center, Houston, Texas, 77043
    • Abigail R. Neiman, MD, PA, Houston, Texas, 77024

  • Oklahoma

    • Lynn Health Science Institute, Oklahoma City, Oklahoma, 73112
    • Cor Clinical Research, Llc, Oklahoma City, Oklahoma, 73103

  • Nebraska

    • Quality Clinical Research, Inc., Omaha, Nebraska, 68114
    • Quality Clinical Research, Inc., Omaha, Nebraska, 68114
    • Heartland Clinical Research, Inc., Omaha, Nebraska, 68134

  • Kansas

    • Kansas City Bone & Joint Clinic, P.A., Overland Park, Kansas, 66211
    • Kansas City Bone & Joint Clinic, P.A., Overland Park, Kansas, 66211

  • Missouri

    • University of Missouri Health Care, Columbia, Missouri, 65212
    • HealthCare Research Network, Hazelwood, Missouri, 63042
    • Medex Healthcare Research, Saint Louis, Missouri, 63117

  • Louisiana

    • Centex Studies, Inc, Lake Charles, Louisiana, 70601

  • Illinois

    • AMR Sakeena Research [Research], Aurora, Illinois, 60506
    • American Medical Research, Oak Brook, Illinois, 60523
    • American Medical Research, Inc., Oak Brook, Illinois, 60523
    • Chicago Anesthesia Associates, Chicago, Illinois, 60657
    • Rehabilitation Institute of Chicago, Chicago, Illinois, 60611

  • Alabama

    • Tennesse Valley Pain Consultants, Huntsville, Alabama, 35801
    • Center for Pain Management, Huntsville, Alabama, 35801
    • The Crawford Clinic, Anniston, Alabama, 36207
    • Pinnacle Research Group, LLC, Anniston, Alabama, 36207
    • Pinnacle Research Group, LLC, Anniston, Alabama, 36207

  • Kentucky

    • OtriMed Corporation, Edgewood, Kentucky, 41017
    • Central Kentucky Research Association, Inc., Lexington, Kentucky, 40509
    • Central Kentucky Research Associates, Inc., Lexington, Kentucky, 40509

  • Ohio

    • Wells Institute for Health Awareness, Kettering, Ohio, 45429

  • Georgia

    • Southeast Regional Research Group, Columbus, Georgia, 31904
    • Georgia Institute for Clinical Research, LLC, Marietta, Georgia, 30060
    • Atlanta Center for Medical Research, Atlanta, Georgia, 30331
    • Atlanta Center for Medical Research, Atlanta, Georgia, 30308
    • Research 1 Clinical Research Network, Inc. (Administrative Office Only), Stockbridge, Georgia, 30281
    • Advanced Internal Medicine, PC, Stockbridge, Georgia, 30281

  • Germany

    • Universitätsklinikum Freiburg, Freiburg, 79106
    • Universitaetsklinikum Freiburg, Freiburg, 79106
    • Schmerztherapiezentrum VS, Villingen-Schwenningen, 78052
    • Gemeinschaftspraxis Dr. M. Leonhardt u. Dr. K. Sallach, Gelsenkirchen, 45879

  • Baden-Württemberg

    • Schmerztherapiezentrum Villingen-Schwenningen, Villingen Schwenningen, Baden-Württemberg, 78052

  • Israel

    • The Chaim Sheba Medical Center, Tel-Hashomer, 52621
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