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ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01057693

Public ClinicalTrials.gov record NCT01057693. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 4:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01057693
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
633 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2010 (Actual)
Primary completion
Jan 30, 2012 (Actual)
Completion
Jan 30, 2012 (Actual)
Last update posted
Jan 20, 2021

2010 – 2012

United States locations

U.S. sites
150
U.S. states
35
U.S. cities
123
Facility City State ZIP Site status
Greystone Medical Research, LLC Birmingham Alabama 35242 —
Neurology Clinic, PC Northport Alabama 35476 —
Horizon Clinical Research Associates, PLLC Gilbert Arizona 85295 —
Dedicated Clinical Research, Inc. Goodyear Arizona 85395 —
Dedicated Clinical Research Goodyear Arizona 85395 —
Novara Clinical Research Mesa Arizona 85206 —
Arizona Research Center Phoenix Arizona 85023 —
Radiant Research, Inc. Scottsdale Arizona 85251 —
Genova Clinical Research, Inc. Tucson Arizona 85704 —
Central Arkansas Research Hot Springs Arkansas 71913 —
Little Rock Diagnostic Clinic Little Rock Arkansas 72205 —
Convergys Clinical Research, Inc. Anaheim California 92805 —
Providence Clinical Research Burbank California 91505 —
Valley Research Fresno California 93720 —
Center for United Research, Inc. Lakewood California 90712 —
Healthcare Partners Medical Group Los Angeles California 90015 —
University of Southern California, Keck School of Medicine, Department of Neurology Los Angeles California 90033 —
Richard S. Cherlin, MD Los Gatos California 95032 —
Northridge Neurological Research Northridge California 91325 —
Remek Research Pomona California 91767 —
Sierra Clinical Research Roseville California 95661 —
CNRI-San Diego, LLC San Diego California 92102 —
San Diego Clinical Trials San Diego California 92120 —
Center for Clinical Research, Inc. San Francisco California 94115 —
Apex Research Institute Santa Ana California 92705 —
Neurological Research Institute Santa Monica California 90404 —
Diablo Clinical Research, Inc. Walnut Creek California 94598 —
Foothills Pain Management West Covina California 91790 —
Aurora Family Medicine Center, PC Aurora Colorado 80012 —
Alpine Clinical Research Center, Inc. Boulder Colorado 80304 —
Mountain View Clinical Research Denver Colorado 80209 —
Chase Medical Research, LLC Waterbury Connecticut 06708 —
Metabolic Research Institute, Inc. Boynton Beach Florida 33472 —
Bradenton Research Center Bradenton Florida 34205 —
Meridien Research Bradenton Florida 34208 —
Meridien Research Brooksville Florida 34601 —
Innovative Research of West Florida, Inc. Clearwater Florida 33756 —
Clinical Research of West Florida, Inc. Clearwater Florida 33765 —
Deerfield Beach Cardiology Research Deerfield Beach Florida 33442 —
Gulfcoast Clinical Research Center Fort Myers Florida 33912 —
MD Clinical Hallandale Florida 33009 —
Elite Research Institute Miami Florida 33169 —
Suncoast Clinical Research, Inc. New Port Richey Florida 34652 —
Laszlo J. Mate, MD North Palm Beach Florida 33408 —
Family Care Specialists, Inc. Ocala Florida 34471 —
Renstar Medical Research Ocala Florida 34471 —
Compass Research, LLC Orlando Florida 32806 —
Palm Beach Neurological Center, Advanced Research Consultants, Inc. Palm Beach Gardens Florida 33418 —
Suncoast Clinical Research Palm Harbor Florida 34684 —
Meridien Research St. Petersburg Florida 33709 —
Neurology Clinical Research, Inc. Sunrise Florida 33351 —
Clinical Research of West Florida, Inc. Tampa Florida 33603 —
Meridien Research Tampa Florida 33606 —
Clinical Research of Central Florida Winter Haven Florida 33880 —
NeuroTrials Research, Incorporated Atlanta Georgia 30342 —
CPM Research Institute Austell Georgia 30106 —
Columbus Research Foundation Columbus Georgia 31904 —
Rockdale Medical Research Associates Conyers Georgia 30094 —
Prism Research Group Rome Georgia 30165 —
Valley Health Care Rome Georgia 30165 —
East-West Medical Research Institute Honolulu Hawaii 96814 —
Advanced Clinical Research Meridian Idaho 83642 —
AMR Sakeena Research Aurora Illinois 60504 —
Chicago Research Center, Inc. Chicago Illinois 60634 —
American Medical Research, Inc. Oak Brook Illinois 60523 —
MediSphere Medical Research Center, LLC Evansville Indiana 47714 —
American Health Network Greenfield Indiana 46140 —
Rehabilitation Associates of Indiana Indianapolis Indiana 46250 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Heartland Research Associates, LLC Wichita Kansas 67207 —
Kentucky Medical Research Center Lexington Kentucky 40504 —
Endocrinology Center of Southwest Louisiana Lake Charles Louisiana 70601 —
Heartland Research, LLC Lake Charles Louisiana 70601 —
Primary Physician Care, LLC Lake Charles Louisiana 70601 —
Arthritis and Diabetes Clinic, Inc Monroe Louisiana 71203 —
Miray Medical Center Brockton Massachusetts 02301 —
Clinical Research Center of Cape Cod, Inc. Hyannis Massachusetts 02601 —
MedVadis Research Corporation Watertown Massachusetts 02472 —
Clinical Pharmacology Study Group Worcester Massachusetts 01605 —
Michigan Head Pain and Neurological Institute Ann Arbor Michigan 48104 —
Harris and Associates MD, PC Detroit Michigan 48235 —
Borgess Diabetes Center Kalamazoo Michigan 49048 —
Borgess Research Institute Kalamazoo Michigan 49048 —
William Beaumont Hospital Royal Oak Michigan 48073 —
KMED Research Saint Clair Shores Michigan 48081 —
William Beaumont Hospital Troy Michigan 48085 —
Troy Internal Medicine, PC Troy Michigan 48098 —
MAPS Applied Research Center, Inc. Edina Minnesota 55435 —
Medical Advanced Pain Specialists (MAPS) Edina Minnesota 55435 —
Medical Advanced Pain Specialists Maple Grove Minnesota 55369 —
Medical Advanced Pain Specialists Shakopee Minnesota 55379 —
CRC of Jackson Jackson Mississippi 39202 —
Physician's Surgery Center Jackson Mississippi 39202 —
Randall T. Huling, Jr., MD, CPI Olive Branch Mississippi 38654 —
University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center Columbia Missouri 65212 —
Melinda A. Crockett-Maples Marionville Missouri 65705 —
Clinvest Springfield Missouri 65807 —
A & A Pain Institute of Saint Louis St Louis Missouri 63141 —
Mercy Health Research St Louis Missouri 63141 —
Lincoln Internal Medicine Associates Lincoln Nebraska 68516 —
Desert Endocrinology Clinical Research Center Henderson Nevada 89052 —
Desert Endocrinology Las Vegas Nevada 89117 —
Office of Dr. Danka Michaels, MD Las Vegas Nevada 89128 —
Office of Stephen Miller, M.D. Las Vegas Nevada 89144 —
Raleigh Neurology Associates, P.A. Raleigh North Carolina 27607-6520 —
Carolina Pharmaceutical Research Statesville North Carolina 28625 —
Radiant Research, Inc. Akron Ohio 44311 —
Community Research Cincinnati Ohio 45245 —
Radiant Research Cincinnati Ohio 45249 —
Hometown Urgent Care and Research Dayton Ohio 45432 —
Providence Health Partners - Center for Clinical Research Dayton Ohio 45439 —
Sooner Clinical Research Oklahoma City Oklahoma 73112 —
Veronique Sebastian, MD Oklahoma City Oklahoma 73120 —
Angelique Barreto, MD Oklahoma City Oklahoma 73134 —
Oregon Health & Science University Portland Oregon 97239-3098 —
Blair Orthopedic Associates, Inc. Altoona Pennsylvania 16602 —
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 —
Research Protocol Management Specialists Pittsburgh Pennsylvania 15243 —
Coastal Medical East Greenwich Rhode Island 02818 —
Memorial Hospital of Rhode Island Pawtucket Rhode Island 02860 —
Omega Medical Research Warwick Rhode Island 02886 —
Aiken Center for Clinical Research Aiken South Carolina 29801 —
TLM Medical Services, LLC Columbia South Carolina 29204 —
Radiant Research Inc. Greer South Carolina 29651 —
Neurology and Pain Clinic, LLC Orangeburg South Carolina 29118 —
University Diabetes & Endocrine Consultants Chattanooga Tennessee 37403 —
SCRI Research Center Germantown Tennessee 38138 —
Sarah Cannon Research Institute Jackson Tennessee 38305 —
AM Diabetes & Endocrinology Center Memphis Tennessee 38133 —
Memphis Internal Medicine Memphis Tennessee 38138 —
ClinRx Research LLC Carrollton Texas 75007 —
Baylor University Medical Center Dallas Texas 75246 —
University of Texas Southwestern Medical Center at Dallas Dallas Texas 75390-8858 —
Medical Group of Texas Fort Worth Texas 76104 —
The Nerve and Muscle Center of Texas Houston Texas 77030 —
ClinRx Research, LLC Richardson Texas 75080 —
Paragon Research Center, LLC San Antonio Texas 78205 —
Alamo Clinical Research San Antonio Texas 78212 —
Cetero Research - San Antonio San Antonio Texas 78229 —
Pioneer Research Solutions, Inc Sugar Land Texas 77479 —
L. Craig Larsen and Clark C. Larsen Murray Utah 84107 —
Aspen Clinical Research Orem Utah 84058 —
Daniel B. Vine, MD Salt Lake City Utah 84107 —
Wasatch Clinical Research Salt Lake City Utah 84107 —
Jean Brown Research Salt Lake City Utah 84124 —
Foot and Ankle Clinic West Jordan Utah 84088 —
Neurological Associates, Incorporated Henrico Virginia 23226 —
National Clinical Research - Norfolk, Inc. Norfolk Virginia 23502 —
Spokane Internal Medicine Spokane Washington 99216 —
Aurora Advanced Healthcare, Inc. Milwaukee Wisconsin 53209 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01057693, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 20, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01057693 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →