Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

Condition(s) targeted: Diabetic Neuropathy, Painful

Intervention: Pregabalin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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

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

Primary outcome: Mean pain score from the daily pain diary

Secondary outcome:

Time to loss of pain response

Proportion of pain responders

Patient Global Impression of Change

Medical Outcomes Study - Sleep Scale

Sleep score from the daily sleep diary

Quality of Life Questionnaire - Diabetic Neuropathy

Pain visual analogue scale

Brief Pain Inventory - short form

Global Evaluation of Study Medication

Hospital Anxiety and Depression Scale

Adverse events

Clinical laboratory tests

Physical & neurological exam, including vital signs and edema assessment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Ponce School of Medicine & Health Sciences, Ponce 00716, Puerto Rico; Active, not recruiting

Instituto de Endocrinologia Diabetes y Metabolismo, Toa Baja 00949, Puerto Rico; Active, not recruiting

Centre for Diabetes and Endocrinology, Houghton, Johannesburg 2198, South Africa; Active, not recruiting

102 Parklands Medical Centre, Overport, Durban 4001, South Africa; Active, not recruiting

Dr's Sauermann and Meyer, Polokwane, South Africa; Active, not recruiting

Clinical Research Unit, University of Pretoria, Pretoria 0002, South Africa; Not yet recruiting
Eluned F Delport, MBCB, Phone: 27 82 924 3458

Diabetes Care Centre, Pretoria 0001, South Africa; Active, not recruiting

Greystone Medical Research, LLC, Birmingham, Alabama 35242, United States; Completed

Neurology Clinic, PC, Northport, Alabama 35476, United States; Active, not recruiting

University of Calgary, Calgary, Alberta T2N4Z6, Canada; Completed

Horizon Clinical Research Associates, PLLC, Gilbert, Arizona 85295, United States; Active, not recruiting

Dedicated Clinical Research, Inc., Goodyear, Arizona 85395, United States; Active, not recruiting

Dedicated Clinical Research, Goodyear, Arizona 85395, United States; Active, not recruiting

Novara Clinical Research, Mesa, Arizona 85206, United States; Terminated

Arizona Research Center, Phoenix, Arizona 85023, United States; Active, not recruiting

Radiant Research, Inc., Scottsdale, Arizona 85251, United States; Active, not recruiting

Genova Clinical Research, Inc., Tucson, Arizona 85704, United States; Active, not recruiting

Central Arkansas Research, Hot Springs, Arkansas 71913, United States; Terminated

Little Rock Diagnostic Clinic, Little Rock, Arkansas 72205, United States; Active, not recruiting

Convergys Clinical Research, Inc., Anaheim, California 92805, United States; Completed

Center for United Research, Inc., Bellflower, California 90706, United States; Completed

Providence Clinical Research, Burbank, California 91505, United States; Completed

Valley Research, Fresno, California 93720, United States; Active, not recruiting

University of Southern California, Keck School of Medicine, Department of Neurology, Los Angeles, California 90033, United States; Active, not recruiting

Healthcare Partners Medical Group, Los Angeles, California 90015, United States; Active, not recruiting

Richard S. Cherlin, MD, Los Gatos, California 95032, United States; Active, not recruiting

Northridge Neurological Research, Northridge, California 91325, United States; Completed

Remek Research, Pomona, California 91767, United States; Terminated

Center for Clinical Research, Inc., Richmond, California 94806, United States; Not yet recruiting
Gary Martinovsky, MD, Phone: 415-710-3061

Sierra Clinical Research, Roseville, California 95661, United States; Completed

CNRI-San Diego, LLC, San Diego, California 92102, United States; Terminated

San Diego Clinical Trials, San Diego, California 92120, United States; Completed

Center for Clinical Research, Inc., San Francisco, California 94115, United States; Active, not recruiting

Apex Research Institute, Santa Ana, California 92705, United States; Completed

Diablo Clinical Research, Inc., Walnut Creek, California 94598, United States; Active, not recruiting

Aurora Family Medicine Center, PC, Aurora, Colorado 80012, United States; Active, not recruiting

Alpine Clinical Research Center, Inc., Boulder, Colorado 80304, United States; Completed

Mountain View Clinical Research, Denver, Colorado 80209, United States; Active, not recruiting

Chase Medical Research, LLC, Waterbury, Connecticut 06708, United States; Recruiting
Joseph Soufer, MD, Phone: 203-419-4420

Metabolic Research Institute, Inc., Boynton Beach, Florida 33472, United States; Terminated

Meridien Research, Bradenton, Florida 34203, United States; Active, not recruiting

Bradenton Research Center, Bradenton, Florida 34205, United States; Active, not recruiting

Clinical Research of West Florida, Inc., Clearwater, Florida 33765, United States; Active, not recruiting

Innovative Research of West Florida, Inc., Clearwater, Florida 33756, United States; Active, not recruiting

Deerfield Beach Cardiology Research, Deerfield Beach, Florida 33442, United States; Terminated

Gulfcoast Clinical Research Center, Ft. Myers, Florida 33912, United States; Active, not recruiting

MD Clinical, Hallandale Beach, Florida 33009, United States; Active, not recruiting

Elite Research Institute, Miami, Florida 33169, United States; Active, not recruiting

Suncoast Clinical Research, Inc., New Port Richey, Florida 34652, United States; Active, not recruiting

Family Care Specialists, Inc., Ocala, Florida 34471, United States; Active, not recruiting

Renstar Medical Research, Ocala, Florida 34471, United States; Active, not recruiting

Compass Research, LLC, Orlando, Florida 32806, United States; Active, not recruiting

Palm Beach Neurological Center, Advanced Research Consultants, Inc., Palm Beach Gardens, Florida 33418, United States; Active, not recruiting

Drug Shipment Address:, Palm Harbor, Florida 34684, United States; Active, not recruiting

Meridien Research, St. Petersburg, Florida 33709, United States; Active, not recruiting

Neurology Clinical Research, Inc., Sunrise, Florida 33351, United States; Active, not recruiting

Clinical Research of West Florida, Inc., Tampa, Florida 33603, United States; Active, not recruiting

Meridien Research, Tampa, Florida 33606, United States; Active, not recruiting

Clinical Research of Central Florida, Winter Haven, Florida 33880, United States; Active, not recruiting

Bloemfontein Medi-Clinic, Bloemfontein, Free State 9301, South Africa; Active, not recruiting

Dr Makan's Rooms, Johannesburg, Gauteng 1827, South Africa; Active, not recruiting

Chris Hani Baragwanath Hospital, Soweto, Gauteng 2013, South Africa; Active, not recruiting

NeuroTrials Research, Incorporated, Atlanta, Georgia 30342, United States; Active, not recruiting

Columbus Research Foundation, Columbus, Georgia 31904, United States; Active, not recruiting

Rockdale Medical Research Associates, Conyers, Georgia 30094, United States; Active, not recruiting

Better Health Clinical Research, Inc., Newnan, Georgia 30265, United States; Completed

Prism Research Group, Rome, Georgia 30165, United States; Active, not recruiting

Valley Health Care, Rome, Georgia 30165, United States; Active, not recruiting

Advanced Clinical Research, Meridian, Idaho 83642, United States; Completed

AMR Sakeena Research, Aurora, Illinois 60504, United States; Active, not recruiting

Chicago Research Center, Inc., Chicago, Illinois 60634, United States; Active, not recruiting

American Medical Research, Inc., Oak Brook, Illinois 60523, United States; Active, not recruiting

MediSphere Medical Research Center, LLC, Evansville, Indiana 47714, United States; Active, not recruiting

Allied Physicians Inc d/b/a Fort Wayne Neurology, Fort Wayne, Indiana 46804, United States; Not yet recruiting
Thomas M Banas, MD, Phone: 260-460-3118

American Health Network, Greenfield, Indiana 46140, United States; Recruiting
Cassandra E Curtis, MD, Phone: 317-462-5252

Rehabilitation Associates of Indiana, Indianapolis, Indiana 46250, United States; Terminated

University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Completed

Heartland Research Associates, LLC, Wichita, Kansas 67207, United States; Active, not recruiting

Kentucky Medical Research Center, Lexington, Kentucky 40504, United States; Active, not recruiting

Randles Road Medical Centre, Durban, Kwa-Zulu Natal 4000, South Africa; Active, not recruiting

Chelmsford Medical Centre, Durban, Kwazulu Natal 4001, South Africa; Active, not recruiting

Parklands Medical Centre, Overport, Kwazulu Natal 4091, South Africa; Active, not recruiting

Dr Jeevren Reddy's Surgery, Stanger, Kwazulu Natal 4450, South Africa; Active, not recruiting

Heartland Research, LLC, Lake Charles, Louisiana 70601, United States; Recruiting
William C Nabours, MD, Phone: 337-474-0361

Primary Physician Care, LLC, Lake Charles, Louisiana 70601, United States; Recruiting
William C Nabours, MD, Phone: 337-474-0361

Endocrinology Center of Southwest Louisiana, Lake Charles, Louisiana 70601, United States; Recruiting
William C Nabours, MD, Phone: 337-474-0361

Arthritis and Diabetes Clinic, Inc, Monroe, Louisiana 71203, United States; Active, not recruiting

Green Clinic LLC, Ruston, Louisiana 71270, United States; Not yet recruiting
Michael E Ehrlich, MD, Phone: 318-251-6352

Winnipeg Health Sciences Centre, Winnipeg, Manitoba R3A 1R9, Canada; Completed

Winnipeg Regional Health Authority Sciences Centre Winnipeg, Winnipeg, Manitoba R3E 3P4, Canada; Completed

Mid-Atlantic Medical Research Centers, Hollywood, Maryland 20636, United States; Recruiting
Nayan R Shah, MD, Phone: 301-373-7551

Miray Medical Center, Brockton, Massachusetts 02301, United States; Active, not recruiting

Clinical Research Center of Cape Cod, Inc., Hyannis, Massachusetts 02601, United States; Active, not recruiting

MedVadis Research Corporation, WaterTown, Massachusetts 02472, United States; Recruiting
Egilius L Spierings, MD, Ph.D., Email: spierings@medvadis.com

Clinical Pharmacology Study Group, Worcester, Massachusetts 01610, United States; Recruiting
Charles A Birbara, MD, Phone: 508-755-0201

Michigan Head Pain and Neurological Institute, Ann Arbor, Michigan 48104, United States; Active, not recruiting

Harris and Associates MD, PC, Detroit, Michigan 48235, United States; Active, not recruiting

Borgess Research Institute, Kalamazoo, Michigan 49048, United States; Active, not recruiting

Borgess Diabetes Center, Kalamazoo, Michigan 49048, United States; Active, not recruiting

William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Completed

KMED Research, St. Clair Shores, Michigan 48081, United States; Terminated

William Beaumont Hospital, Troy, Michigan 48085, United States; Completed

Troy Internal Medicine, PC, Troy, Michigan 48098, United States; Completed

MAPS Applied Research Center, Inc., Edina, Minnesota 55435, United States; Completed

Medical Advanced Pain Specialists, Maple Grove, Minnesota 55369, United States; Completed

Medical Advanced Pain Specialists, Shakopee, Minnesota 55379, United States; Completed

CRC of Jackson, Jackson, Mississippi 39202, United States; Terminated

Physician's Surgery Center, Jackson, Mississippi 39202, United States; Terminated

Randall T. Huling, Jr., MD, CPI, Olive Branch, Mississippi 38654, United States; Active, not recruiting

University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center, Columbia, Missouri 65212, United States; Active, not recruiting

Melinda A. Crockett-Maples, Marionville, Missouri 65705, United States; Recruiting
Melinda A Crockett-Maples, MD, Phone: 417-258-7200

Clinvest, Springfield, Missouri 65807, United States; Recruiting
Melinda A Crockett-Maples, MD, Phone: 417-258-7200

A & A Pain Institute of Saint Louis, St Louis, Missouri 63141, United States; Active, not recruiting

Mercy Health Research, St. Louis, Missouri 63141, United States; Active, not recruiting

Lincoln Internal Medicine Associates, Lincoln, Nebraska 68516, United States; Completed

Desert Endocrinology Clinical Research Center, Henderson, Nevada 89052, United States; Recruiting
William R Litchfield, MD, Phone: 702-949-7785

Office of Stephen Miller, M.D., Las Vegas, Nevada 89144, United States; Recruiting
Stephen H Miller, MD, Phone: 702-464-7115

Desert Endocrinology, Las Vegas, Nevada 89117, United States; Recruiting
Milton K Wong, MD, Phone: 702-243-8204

Office of Dr. Danka Michaels, MD, Las Vegas, Nevada 89128, United States; Completed

Carolina Pharmaceutical Research, Statesville, North Carolina 28625, United States; Completed

Peidmont Healthcare, Statesville, North Carolina 28625, United States; Completed

Capital District Health Authority, Division of Endocrinology, Halifax, Nova Scotia B3H 2Y9, Canada; Completed

Capital District Health Authority, Halifax, Nova Scotia B3H 1V7, Canada; Completed

Radiant Research, Inc., Akron, Ohio 44311, United States; Active, not recruiting

Community Research, Cincinnati, Ohio 45245, United States; Terminated

Radiant Research, Cincinnati, Ohio 45249, United States; Terminated

Providence Health Partners - Center for Clinical Research, Dayton, Ohio 45439, United States; Active, not recruiting

Hometown Urgent Care and Research, Dayton, Ohio 45432, United States; Recruiting
Steve H Choi, MD, Phone: 937-252-2000 x383

Sooner Clinical Research, Oklahoma City, Oklahoma 73112, United States; Active, not recruiting

Angelique Barreto, MD, Oklahoma City, Oklahoma 73134, United States; Active, not recruiting

Veronique Sebastian, MD, Oklahoma City, Oklahoma 73120, United States; Active, not recruiting

The Ottawa Hospital, Riverside Campus - Riverside Professional Building, Ottawa, Ontario K1H 1A2, Canada; Completed

Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada; Completed

Oregon Health & Science University, Portland, Oregon 97239-3098, United States; Terminated

Study drug shipments should be sent to:, Portland, Oregon 97239, United States; Terminated

Dot Shuttleworth Centre for Diabetes, Durban, Overport 4091, South Africa; Active, not recruiting

Blair Orthopedic Associates, Inc., Altoona, Pennsylvania 16602, United States; Recruiting
Adam M Budny, DPM, Phone: 814-942-1166

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States; Active, not recruiting

Research Protocol Management Specialists, Pittsburg, Pennsylvania 15243, United States; Recruiting
Mark E Hospodar, Phone: 412-942-0010

Coastal Medical, East Greenwich, Rhode Island 02818, United States; Active, not recruiting

Memorial Hospital of Rhode Island, Pawtucket, Rhode Island 02860, United States; Active, not recruiting

Omega Medical Research, Warwick, Rhode Island 02886, United States; Active, not recruiting

Aiken Center for Clinical Research, Aiken, South Carolina 29801, United States; Terminated

TLM Medical Services, LLC, Columbia, South Carolina 29204, United States; Active, not recruiting

Radiant Research Inc., Greer, South Carolina 29651, United States; Active, not recruiting

Neurology and Pain Clinic, LLC, Orangeburg, South Carolina 29118, United States; Active, not recruiting

AM Diabetes & Endocrinology Center, Bartlett, Tennessee 38133, United States; Active, not recruiting

University Diabetes & Endocrine Consultants, Chattanooga, Tennessee 37403, United States; Recruiting
David M Huffman, Phone: 423-265-3561

SCRI Research Center, Germantown, Tennessee 38138, United States; Terminated

Sarah Cannon Research Institute, Jackson, Tennessee 38305, United States; Terminated

Memphis Internal Medicine, Memphis, Tennessee 38138, United States; Completed

Lovelace Scientific Resources, Inc., Austin, Texas 78758, United States; Not yet recruiting
Everett G Heinze, MD, Phone: 512-901-8860

ClinRx Research LLC, Carrollton, Texas 75007, United States; Active, not recruiting

Baylor University Medical Center, Dallas, Texas 75246, United States; Active, not recruiting

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-8858, United States; Active, not recruiting

Medical Group of Texas, Ft. Worth, Texas 76104, United States; Completed

The Nerve and Muscle Center of Texas, Houston, Texas 77030, United States; Active, not recruiting

ClinRx Research, LLC, Richardson, Texas 75080, United States; Active, not recruiting

Cetero Research - San Antonio, San Antonio, Texas 78229, United States; Active, not recruiting

Paragon Research Center, LLC, San Antonio, Texas 78205, United States; Active, not recruiting

Alamo Clinical Research, San Antonio, Texas 78212, United States; Active, not recruiting

Pioneer Research Solutions, Inc, Sugar Land, Texas 77479, United States; Active, not recruiting

L. Craig Larsen and Clark C. Larsen, Murray, Utah 84107, United States; Active, not recruiting

Aspen Clinical Research, Orem, Utah 84058, United States; Active, not recruiting

Wasatch Clinical Research, Salt Lake City, Utah 84107, United States; Active, not recruiting

Daniel B. Vine, MD, Salt Lake City, Utah 84107, United States; Active, not recruiting

Jean Brown Research, Salt Lake City, Utah 84124, United States; Active, not recruiting

Foot and Ankle Clinic, West Jordan, Utah 84088, United States; Active, not recruiting

Neurological Associates, Incorporated, Henrico, Virginia 23226, United States; Terminated

National Clinical Research - Norfolk, Inc., Norfolk, Virginia 23502, United States; Terminated

Spokane Internal Medicine, Spokane, Washington 99216, United States; Completed

Aurora Advanced Healthcare, Inc., Milwaukee, Wisconsin 53209, United States; Active, not recruiting

To obtain contact information for a study center near you, click here.

Starting date: March 2010
Last updated: November 23, 2011