Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
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
2 other identifiers
interventional
633
4 countries
172
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2010
172 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedStudy Start
First participant enrolled
March 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2012
CompletedResults Posted
Study results publicly available
February 22, 2013
CompletedJanuary 20, 2021
February 1, 2019
1.8 years
January 26, 2010
January 18, 2013
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
SB Baseline, Week 19 (DB Phase)
Secondary Outcomes (26)
Time to Loss of Pain Response (Double-Blind Phase)
SB Baseline up to Week 19
Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase
SB Baseline, Week 6 (SB Phase)
Weekly Mean Pain Scores (Single-Blind Phase)
Week 1, 2, 3, 4, 5, 6
Weekly Mean Pain Scores (Double-Blind Phase)
DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)
Week 6
- +21 more secondary outcomes
Study Arms (2)
pregabalin (Lyrica)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
Eligibility Criteria
You may qualify if:
- Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.
You may not qualify if:
- Patients with other pain conditions cannot participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (172)
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, Inc.
Goodyear, Arizona, 85395, United States
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
Novara Clinical Research
Mesa, Arizona, 85206, United States
Arizona Research Center
Phoenix, Arizona, 85023, 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
Providence Clinical Research
Burbank, California, 91505, United States
Valley Research
Fresno, California, 93720, United States
Center for United Research, Inc.
Lakewood, California, 90712, United States
Healthcare Partners Medical Group
Los Angeles, California, 90015, United States
University of Southern California, Keck School of Medicine, Department of Neurology
Los Angeles, California, 90033, 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
Sierra Clinical Research
Roseville, California, 95661, United States
CNRI-San Diego, LLC
San Diego, California, 92102, United States
San Diego Clinical Trials
San Diego, California, 92120, 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
Foothills Pain Management
West Covina, California, 91790, 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
Bradenton Research Center
Bradenton, Florida, 34205, United States
Meridien Research
Bradenton, Florida, 34208, 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
Fort Myers, Florida, 33912, United States
MD Clinical
Hallandale, 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
Family Care Specialists, Inc.
Ocala, Florida, 34471, United States
Renstar Medical Research
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
Meridien Research
St. Petersburg, Florida, 33709, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Meridien Research
Tampa, Florida, 33606, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
NeuroTrials Research, Incorporated
Atlanta, Georgia, 30342, United States
CPM Research Institute
Austell, Georgia, 30106, United States
Columbus Research Foundation
Columbus, Georgia, 31904, United States
Rockdale Medical Research Associates
Conyers, Georgia, 30094, 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
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
Heartland Research, LLC
Lake Charles, Louisiana, 70601, United States
Primary Physician Care, LLC
Lake Charles, Louisiana, 70601, United States
Arthritis and Diabetes Clinic, Inc
Monroe, Louisiana, 71203, 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, 01605, 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
Saint Clair Shores, Michigan, 48081, United States
William Beaumont Hospital
Troy, Michigan, 48085, United States
Troy Internal Medicine, PC
Troy, Michigan, 48098, United States
MAPS Applied Research Center, Inc.
Edina, Minnesota, 55435, United States
Medical Advanced Pain Specialists (MAPS)
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
Desert Endocrinology
Las Vegas, Nevada, 89117, 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
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607-6520, United States
Carolina Pharmaceutical Research
Statesville, North Carolina, 28625, 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
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Veronique Sebastian, MD
Oklahoma City, Oklahoma, 73120, United States
Angelique Barreto, MD
Oklahoma City, Oklahoma, 73134, 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
Pittsburgh, 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
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
AM Diabetes & Endocrinology Center
Memphis, Tennessee, 38133, United States
Memphis Internal Medicine
Memphis, Tennessee, 38138, United States
ClinRx Research LLC
Carrollton, Texas, 75007, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8858, United States
Medical Group of Texas
Fort 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
Alamo Clinical Research
San Antonio, Texas, 78212, United States
Cetero Research - San Antonio
San Antonio, Texas, 78229, 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
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Jean Brown Research
Salt Lake City, Utah, 84124, 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 Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Winnipeg Regional Health Authority Sciences Centre Winnipeg
Winnipeg, Manitoba, R3E 3P4, Canada
Capital District Health Authority, QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Capital District Health Authority, QEII Health Sciences Centre
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, KwaZulu-Natal, 4000, South Africa
Chelmsford Medical Centre
Durban, KwaZulu-Natal, 4001, South Africa
Centre for Diabetes and Endocrinology
Durban, KwaZulu-Natal, 4091, South Africa
Dr Jeevren Reddy's Surgery
KwaDukuza, KwaZulu-Natal, 4450, South Africa
Parklands Medical Centre
Overport, KwaZulu-Natal, 4091, 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
Related Publications (1)
Raskin P, Huffman C, Toth C, Asmus MJ, Messig M, Sanchez RJ, Pauer L. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014 May;30(5):379-90. doi: 10.1097/AJP.0b013e31829ea1a1.
PMID: 23887339DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
March 31, 2010
Primary Completion
January 30, 2012
Study Completion
January 30, 2012
Last Updated
January 20, 2021
Results First Posted
February 22, 2013
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.