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A Phase 3b Multicenter, Double-Blind, Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy

This study is currently Recruiting

October 2011 By Pfizer

First Recieved on January 26, 2010

Last Updated on October 26, 2011

Sponsor: Pfizer
Collaborators:
Information provided by: Pfizer
Identifier: NCT01057693

Purpose

Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition. Exclusion Criteria: - Patients with other pain conditions cannot participate.

Investigators

  • Investigator: Pfizer CT.gov Call Center - Study Director - Pfizer

Locations

  • Greystone Medical Research, LLC

    Birmingham, Alabama 35242 United States

  • Neurology Clinic, PC

    Northport, Alabama 35476 United States

  • Horizon Clinical Research Associates, PLLC

    Gilbert, Arizona 85295 United States

  • Dedicated Clinical Research

    Goodyear, Arizona 85395 United States

  • Dedicated Clinical Research, Inc.

    Goodyear, Arizona 85395 United States

  • Novara Clinical Research

    Mesa, Arizona 85206 United States

  • Arizona Research Center

    Phoenix, Arizona 85023 United States

  • 21st Century Neurology- Division of Xenoscience, Inc.

    Phoenix, Arizona 85004 United States

  • Radiant Research, Inc.

    Scottsdale, Arizona 85251 United States

  • Genova Clinical Research, Inc.

    Tucson, Arizona 85704 United States

  • Central Arkansas Research

    Hot Springs, Arkansas 71913 United States

  • Little Rock Diagnostic Clinic

    Little Rock, Arkansas 72205 United States

  • Convergys Clinical Research, Inc.

    Anaheim, California 92805 United States

  • Center for United Research, Inc.

    Bellflower, California 90706 United States

  • Providence Clinical Research

    Burbank, California 91505 United States

  • Valley Research

    Fresno, California 93720 United States

  • University of Southern California, Keck School of Medicine, Department of Neurology

    Los Angeles, California 90033 United States

  • Healthcare Partners Medical Group

    Los Angeles, California 90015 United States

  • Richard S. Cherlin, MD

    Los Gatos, California 95032 United States

  • Northridge Neurological Research

    Northridge, California 91325 United States

  • Remek Research

    Pomona, California 91767 United States

  • Center for Clinical Research, Inc.

    Richmond, California 94806 United States

  • Sierra Clinical Research

    Roseville, California 95661 United States

  • San Diego Clinical Trials

    San Diego, California 92120 United States

  • CNRI-San Diego, LLC

    San Diego, California 92102 United States

  • Center for Clinical Research, Inc.

    San Francisco, California 94115 United States

  • Apex Research Institute

    Santa Ana, California 92705 United States

  • Neurological Research Institute

    Santa Monica, California 90404 United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598 United States

  • Aurora Family Medicine Center, PC

    Aurora, Colorado 80012 United States

  • Alpine Clinical Research Center, Inc.

    Boulder, Colorado 80304 United States

  • Mountain View Clinical Research

    Denver, Colorado 80209 United States

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708 United States

  • Metabolic Research Institute, Inc.

    Boynton Beach, Florida 33472 United States

  • Meridien Research

    Bradenton, Florida 34203 United States

  • Bradenton Research Center

    Bradenton, Florida 34205 United States

  • Meridien Research

    Brooksville, Florida 34601 United States

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida 33756 United States

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765 United States

  • Deerfield Beach Cardiology Research

    Deerfield Beach, Florida 33442 United States

  • Gulfcoast Clinical Research Center

    Ft. Myers, Florida 33912 United States

  • MD Clinical

    Hallandale Beach, Florida 33009 United States

  • Elite Research Institute

    Miami, Florida 33169 United States

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652 United States

  • Laszlo J. Mate, MD

    North Palm Beach, Florida 33408 United States

  • Renstar Medical Research

    Ocala, Florida 34471 United States

  • Family Care Specialists, Inc.

    Ocala, Florida 34471 United States

  • Compass Research, LLC

    Orlando, Florida 32806 United States

  • Palm Beach Neurological Center, Advanced Research Consultants, Inc.

    Palm Beach Gardens, Florida 33418 United States

  • Suncoast Clinical Research

    Palm Harbor, Florida 34684 United States

  • Drug Shipment Address:

    Palm Harbor, Florida 34684 United States

  • Meridien Research

    St. Petersburg, Florida 33709 United States

  • Neurology Clinical Research, Inc.

    Sunrise, Florida 33351 United States

  • Sunrise Clinical Research, Inc.

    Tamarac, Florida 33321 United States

  • Meridien Research

    Tampa, Florida 33606 United States

  • Clinical Research of West Florida, Inc.

    Tampa, Florida 33603 United States

  • Clinical Research of Central Florida

    Winter Haven, Florida 33880 United States

  • NeuroTrials Research, Incorporated

    Atlanta, Georgia 30342 United States

  • Columbus Research Foundation

    Columbus, Georgia 31904 United States

  • Rockdale Medical Research Associates

    Conyers, Georgia 30094 United States

  • Better Health Clinical Research, Inc.

    Newnan, Georgia 30265 United States

  • Prism Research Group

    Rome, Georgia 30165 United States

  • Valley Health Care

    Rome, Georgia 30165 United States

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814 United States

  • Advanced Clinical Research

    Meridian, Idaho 83642 United States

  • AMR Sakeena Research

    Aurora, Illinois 60504 United States

  • Chicago Research Center, Inc.

    Chicago, Illinois 60634 United States

  • American Medical Research, Inc.

    Oak Brook, Illinois 60523 United States

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714 United States

  • Allied Physicians Inc d/b/a Fort Wayne Neurology

    Fort Wayne, Indiana 46804 United States

  • American Health Network

    Greenfield, Indiana 46140 United States

  • Rehabilitation Associates of Indiana

    Indianapolis, Indiana 46250 United States

  • University of Kansas Medical Center

    Kansas City, Kansas 66160 United States

  • Heartland Research Associates, LLC

    Wichita, Kansas 67207 United States

  • Kentucky Medical Research Center

    Lexington, Kentucky 40504 United States

  • Endocrinology Center of Southwest Louisiana

    Lake Charles, Louisiana 70601 United States

  • Primary Physician Care, LLC

    Lake Charles, Louisiana 70601 United States

  • Heartland Research, LLC

    Lake Charles, Louisiana 70601 United States

  • Arthritis and Diabetes Clinic, Inc

    Monroe, Louisiana 71203 United States

  • Green Clinic LLC

    Ruston, Louisiana 71270 United States

  • Mid-Atlantic Medical Research Centers

    Hollywood, Maryland 20636 United States

  • Miray Medical Center

    Brockton, Massachusetts 02301 United States

  • Clinical Research Center of Cape Cod, Inc.

    Hyannis, Massachusetts 02601 United States

  • MedVadis Research Corporation

    WaterTown, Massachusetts 02472 United States

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01610 United States

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan 48104 United States

  • Harris and Associates MD, PC

    Detroit, Michigan 48235 United States

  • Borgess Diabetes Center

    Kalamazoo, Michigan 49048 United States

  • Borgess Research Institute

    Kalamazoo, Michigan 49048 United States

  • William Beaumont Hospital

    Royal Oak, Michigan 48073 United States

  • KMED Research

    St. Clair Shores, Michigan 48081 United States

  • Troy Internal Medicine, PC

    Troy, Michigan 48098 United States

  • William Beaumont Hospital

    Troy, Michigan 48085 United States

  • Medical Advanced Pain Specialists (MAPS)

    Edina, Minnesota 55435 United States

  • MAPS Applied Research Center, Inc.

    Edina, Minnesota 55435 United States

  • Medical Advanced Pain Specialists

    Maple Grove, Minnesota 55369 United States

  • Medical Advanced Pain Specialists

    Shakopee, Minnesota 55379 United States

  • CRC of Jackson

    Jackson, Mississippi 39202 United States

  • Physician's Surgery Center

    Jackson, Mississippi 39202 United States

  • Randall T. Huling, Jr., MD, CPI

    Olive Branch, Mississippi 38654 United States

  • University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center

    Columbia, Missouri 65212 United States

  • Melinda A. Crockett-Maples

    Marionville, Missouri 65705 United States

  • Clinvest

    Springfield, Missouri 65807 United States

  • A & A Pain Institute of Saint Louis

    St Louis, Missouri 63141 United States

  • Mercy Health Research

    St. Louis, Missouri 63141 United States

  • Lincoln Internal Medicine Associates

    Lincoln, Nebraska 68516 United States

  • Desert Endocrinology Clinical Research Center

    Henderson, Nevada 89052 United States

  • Office of Dr. Danka Michaels, MD

    Las Vegas, Nevada 89128 United States

  • Office of Stephen Miller, M.D.

    Las Vegas, Nevada 89144 United States

  • Desert Endocrinology

    Las Vegas, Nevada 89117 United States

  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina 27607-6520 United States

  • Peidmont Healthcare

    Statesville, North Carolina 28625 United States

  • Carolina Pharmaceutical Research

    Statesville, North Carolina 28625 United States

  • The Center for Clinical Research

    Winston-Salem, North Carolina 27103 United States

  • Radiant Research, Inc.

    Akron, Ohio 44311 United States

  • Community Research

    Cincinnati, Ohio 45245 United States

  • Radiant Research

    Cincinnati, Ohio 45249 United States

  • Hometown Urgent Care and Research

    Dayton, Ohio 45432 United States

  • Providence Health Partners - Center for Clinical Research

    Dayton, Ohio 45439 United States

  • Angelique Barreto, MD

    Oklahoma City, Oklahoma 73134 United States

  • Veronique Sebastian, MD

    Oklahoma City, Oklahoma 73120 United States

  • Sooner Clinical Research

    Oklahoma City, Oklahoma 73112 United States

  • Study drug shipments should be sent to:

    Portland, Oregon 97239 United States

  • Oregon Health & Science University

    Portland, Oregon 97239-3098 United States

  • Blair Orthopedic Associates, Inc.

    Altoona, Pennsylvania 16602 United States

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635 United States

  • Research Protocol Management Specialists

    Pittsburg, Pennsylvania 15243 United States

  • Coastal Medical

    East Greenwich, Rhode Island 02818 United States

  • Memorial Hospital of Rhode Island

    Pawtucket, Rhode Island 02860 United States

  • Omega Medical Research

    Warwick, Rhode Island 02886 United States

  • Aiken Center for Clinical Research

    Aiken, South Carolina 29801 United States

  • TLM Medical Services, LLC

    Columbia, South Carolina 29204 United States

  • Radiant Research Inc.

    Greer, South Carolina 29651 United States

  • Neurology and Pain Clinic, LLC

    Orangeburg, South Carolina 29118 United States

  • AM Diabetes & Endocrinology Center

    Bartlett, Tennessee 38133 United States

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee 37403 United States

  • SCRI Research Center

    Germantown, Tennessee 38138 United States

  • Sarah Cannon Research Institute

    Jackson, Tennessee 38305 United States

  • Memphis Internal Medicine

    Memphis, Tennessee 38138 United States

  • Lovelace Scientific Resources, Inc.

    Austin, Texas 78758 United States

  • ClinRx Research LLC

    Carrollton, Texas 75007 United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75390-8858 United States

  • Baylor University Medical Center

    Dallas, Texas 75246 United States

  • Medical Group of Texas

    Ft. Worth, Texas 76104 United States

  • The Nerve and Muscle Center of Texas

    Houston, Texas 77030 United States

  • ClinRx Research, LLC

    Richardson, Texas 75080 United States

  • Paragon Research Center, LLC

    San Antonio, Texas 78205 United States

  • Cetero Research - San Antonio

    San Antonio, Texas 78229 United States

  • Alamo Clinical Research

    San Antonio, Texas 78212 United States

  • Pioneer Research Solutions, Inc

    Sugar Land, Texas 77479 United States

  • L. Craig Larsen and Clark C. Larsen

    Murray, Utah 84107 United States

  • Aspen Clinical Research

    Orem, Utah 84058 United States

  • Daniel B. Vine, MD

    Salt Lake City, Utah 84107 United States

  • Jean Brown Research

    Salt Lake City, Utah 84124 United States

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107 United States

  • Foot and Ankle Clinic

    West Jordan, Utah 84088 United States

  • Neurological Associates, Incorporated

    Henrico, Virginia 23226 United States

  • National Clinical Research - Norfolk, Inc.

    Norfolk, Virginia 23502 United States

  • Spokane Internal Medicine

    Spokane, Washington 99216 United States

  • Aurora Advanced Healthcare, Inc.

    Milwaukee, Wisconsin 53209 United States

  • University of Calgary

    Calgary, Alberta T2N4Z6 Canada

  • Winnipeg Regional Health Authority Sciences Centre Winnipeg

    Winnipeg, Manitoba R3E 3P4 Canada

  • Winnipeg Health Sciences Centre

    Winnipeg, Manitoba R3A 1R9 Canada

  • Capital District Health Authority

    Halifax, Nova Scotia B3H 1V7 Canada

  • Capital District Health Authority, Division of Endocrinology

    Halifax, Nova Scotia B3H 2Y9 Canada

  • The Ottawa Hospital, Riverside Campus - Riverside Professional Building

    Ottawa, Ontario K1H 1A2 Canada

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4 Canada

  • Ponce School of Medicine & Health Sciences

    Ponce, 00716 Puerto Rico

  • Instituto de Endocrinologia Diabetes y Metabolismo

    Toa Baja, 00949 Puerto Rico

  • Bloemfontein Medi-Clinic

    Bloemfontein, Free State 9301 South Africa

  • Dr Makan's Rooms

    Johannesburg, Gauteng 1827 South Africa

  • Chris Hani Baragwanath Hospital

    Soweto, Gauteng 2013 South Africa

  • Randles Road Medical Centre

    Durban, Kwa-Zulu Natal 4000 South Africa

  • Chelmsford Medical Centre

    Durban, Kwazulu Natal 4001 South Africa

  • Parklands Medical Centre

    Overport, Kwazulu Natal 4091 South Africa

  • Dr Jeevren Reddy's Surgery

    Stanger, Kwazulu Natal 4450 South Africa

  • Dot Shuttleworth Centre for Diabetes

    Durban, Overport 4091 South Africa

  • Centre for Diabetes and Endocrinology

    Houghton, Johannesburg, 2198 South Africa

  • 102 Parklands Medical Centre

    Overport, Durban, 4001 South Africa

  • Dr's Sauermann and Meyer

    Polokwane, South Africa

  • Diabetes Care Centre

    Pretoria, 0001 South Africa

  • Clinical Research Unit, University of Pretoria

    Pretoria, 0002 South Africa

Conditions related to this trial:

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