Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
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
2 other identifiers
interventional
542
13 countries
156
Brief Summary
This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2012
Typical duration for phase_3
156 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
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
June 7, 2017
CompletedJanuary 28, 2021
April 1, 2017
2.8 years
October 3, 2012
July 20, 2016
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Baseline Mean Pain Score
This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Baseline
Change From Baseline to Week 15 in Weekly Mean Pain Score
This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
up to Week 15
Secondary Outcomes (10)
Patient Global Impression of Change (PGIC) at Week 15
Week 15
Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)
up to Week 15
Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])
Week 15
Change From Baseline in Pain Interference Index (BPI-sf)
Week 15
Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores
Week 15
- +5 more secondary outcomes
Study Arms (2)
pregabalin
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (156)
Tennesse Valley Pain Consultants
Huntsville, Alabama, 35801, United States
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
HOPE Research Institute
Phoenix, Arizona, 85018, United States
The Pain Center of Arizona
Phoenix, Arizona, 85018, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
The Pain Center of Arizona
Phoenix, Arizona, 85027, United States
Neuromuscular Research Center
Phoenix, Arizona, 85028, United States
Quality of Life Medical & Research Centers, LLC
Tucson, Arizona, 85712, United States
Advanced Rx Clinical Research
Artesia, California, 90701, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
NervePro Medical Corp.
Irvine, California, 92618, United States
University of California, Irvine
Irvine, California, 92697, United States
Clinical and Translational Research Institute
La Jolla, California, 92093, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
South Orange County Surgical Medical Group
Laguna Hills, California, 92653, United States
Center For United Research, Inc.
Lakewood, California, 90805, United States
University of Southern California
Los Angeles, California, 90033, United States
USC I.D.S. Pharmacy
Los Angeles, California, 90089, United States
Samaritan Center for Medical Research
Los Gatos, California, 95032, United States
North County Clinical Research
Oceanside, California, 92056, United States
Allied Clinical Research
Roseville, California, 95661, United States
Northern California Research
Sacramento, California, 95821, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Elite Clinical Trials, Inc.
Wildomar, California, 92595, United States
Colorado Clinic
Boulder, Colorado, 80301, United States
Mountain View Clinical Research Inc.
Denver, Colorado, 80209, United States
St. Luke's Medical Clinic
Fort Collins, Colorado, 80525, United States
Investigational Drug Services, The George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
The George Washington University Medical Center (Department of Neurology)
Washington D.C., District of Columbia, 20037, United States
The George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Advance Medical Research
Clearwater, Florida, 33756, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
Aga Clinical Trials
Hialeah, Florida, 33012, United States
Health Care Family Rehab & Research Center
Hialeah, Florida, 33012, United States
Research in Miami, Inc.
Hialeah, Florida, 33013, United States
Homestead Medical Research , Inc.
Homestead, Florida, 33030, United States
San Marcus Research Clinic, Inc.
Miami, Florida, 33015, United States
Advanced Pharma CR, LLC
Miami, Florida, 33136, United States
Florida International Research Center
Miami, Florida, 33173, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
AMPM Research Clinic
Miami Gardens, Florida, 33169, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
A-One Family Practice
Ormond Beach, Florida, 32174, United States
Aba Family Medicine, LLC
Ormond Beach, Florida, 32174, United States
Ribo Research, LLC dba Peninsula Resarch
Ormond Beach, Florida, 32174, United States
Comprehensive Pain Care of South Florida
Royal Palm Beach, Florida, 33411, United States
Sarasota Pain Medicine Research
Sarasota, Florida, 34238, United States
Meridien Research
Tampa, Florida, 33634, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Advanced Internal Medicine, PC
Stockbridge, Georgia, 30281, United States
Research 1 Clinical Research Network, Inc. (Administrative Office Only)
Stockbridge, Georgia, 30281, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Chicago Anesthesia Associates
Chicago, Illinois, 60657, United States
Kansas City Bone & Joint Clinic
Overland Park, Kansas, 66211, United States
Otri-Med Corporation
Edgewood, Kentucky, 41017, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Centex Studies, Inc
Lake Charles, Louisiana, 70601, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Heartland Clinical Research, Inc.
Omaha, Nebraska, 68134, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
University of Rochester, Translational Pain Research
Rochester, New York, 14618, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28209, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Northern Ohio Neurosciences, LLC
Bellevue, Ohio, 44811, United States
Wells Institute for Health Awareness
Kettering, Ohio, 45429, United States
Northwest Ohio Research Center, LLC
Toledo, Ohio, 43623, United States
Robert L Kalb, M.D, Inc
Toledo, Ohio, 43623, United States
Cor Clinical Research, Llc
Oklahoma City, Oklahoma, 73103, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Summit Research Network, Inc.
Portland, Oregon, 97210, United States
Allegheny Pain Management, P.C.
Altoona, Pennsylvania, 16602, United States
CRI Lifetree
Philadelphia, Pennsylvania, 19139, United States
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, 29412, United States
TLM Medical Services, LLC
Columbia, South Carolina, 29204, United States
Piedmont Comprehensive Pain Management Group, LLC
Greenville, South Carolina, 29601, United States
Pharmacum Biomedical Research
Greenville, South Carolina, 29605, United States
New Phase Research and Development
Knoxville, Tennessee, 37919, United States
Dallas Pain Consultants
Dallas, Texas, 75203, United States
FutureSearch Trials of Dallas, L. P.
Dallas, Texas, 75231, United States
Abigail R. Neiman, MD, PA
Houston, Texas, 77024, United States
Agadadash Kuliev, MD, PA
Houston, Texas, 77043, United States
Biopharma Informatic Inc. Research Center
Houston, Texas, 77043, United States
Medstar Clinical Research Associates
Houston, Texas, 77083, United States
ClinRx Research, LLC
Richardson, Texas, 75080, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Sealy Urgent Care Center and Medical Clinic
Sealy, Texas, 77474, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
J. Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewish Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Integrated Neurology Services , PLLC
Arlington, Virginia, 22205, United States
IntegraTrials, LLC
Arlington, Virginia, 22205, United States
Washington Center for Pain Management LLC
Bellevue, Washington, 98004, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Washington Center for Pain Management LLC
Edmonds, Washington, 98026, United States
Washington Center for Pain Management LLC
Everett, Washington, 98201, United States
Washington Center for Pain Management LLC
Renton, Washington, 98055, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104, United States
MHAT Puls AD
Blagoevgrad, 2700, Bulgaria
MHAT "Avis Medika"
Pleven, 5800, Bulgaria
MHAT "Sv.Pantaleymon"
Pleven, 5800, Bulgaria
DCC Akta Medika Ltd.
Sevlievo, 5400, Bulgaria
UMHAT Aleksandrovska
Sofia, 1431, Bulgaria
DCC "Sveta Anna"EOOD
Sofia, 1709, Bulgaria
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
NRK Medical Research Clinic (Adminstrative Office Only)
London, Ontario, N6H 4P2, Canada
NRK Medical Research Clinic
London, Ontario, N6H 4P2, Canada
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, N7T 4X3, Canada
General Hospital "dr. Ivo Pedisic"
Sisak, 44000, Croatia
Glostrup Hospital
Glostrup Municipality, 2600, Denmark
Klinische Forschung Hannover-Mitte GmbH
Hanover, Lower Saxony, 30159, Germany
Praxis für Spezielle Schmerztherapie und Palliativmedizin
Böhlen, Saxony, 04564, Germany
medamed GmbH Studienambulanz
Leipzig, Saxony, 04109, Germany
pro scientia med im MARE Klinikum
Kiel-Kronshagen, Schleswig-Holstein, 24119, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Synexus Clinical Research GmbH
Berlin, 12627, Germany
Synexus Clinical Research GmbH
Bochum, 44787, Germany
Synexus Clinical Research GmbH
Frankfurt, 60596, Germany
Klinische Forschung Hamburg GmbH
Hamburg, 20253, Germany
Gemeinschaftspraxis für Schmerz- und Psychotherapie
Hamburg, 22767, Germany
Synexus Clinical Research GmbH
Leipzig, 04103, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
Synexus Magyarorszag Kft.
Budapest, 1036, Hungary
UNO Medical Trials Kft
Budapest, 1135, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526, Hungary
Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z.o.o.
Gdansk, 80-286, Poland
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-384, Poland
"Synexus Polska" Sp. z o.o. Oddzial W Katowicach
Katowice, 40-040, Poland
Malopolskie Centrum Medyczne S.C.
Krakow, 30-510, Poland
NZOZ IGNIS dr n. med. Alicja Lobinska
Świdnik, 21-040, Poland
"SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE
Warsaw, 01-192, Poland
"SYNEXUS POLSKA" Sp. z o.o. Odzial we Wroclawiu
Wroclaw, 50-088, Poland
Ponce School of Medicine, CAIMED Center
Ponce, 00716, Puerto Rico
Centrul Medical Sana
Bucharest, 011025, Romania
Clubul Sanatatii SRL
Campulung Muscel, 115100, Romania
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, 200473, Romania
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea,Sectia Neurologie I
Oradea, 410154, Romania
Spitalul Clinic Judetean de Urgenta Sibiu,Sectia Neurologie
Sibiu, 550166, Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures , Sectia Neurologie II
Târgu Mureş, 540136, Romania
Welkom Clinical Trial Centre
Welkom, Free State, 9460, South Africa
Synexus SA - Stanza Clinical Research Centre
Pretoria, Gauteng, 0122, South Africa
Synexus SA - Watermeyer Clinical Research Centre
Pretoria, Gauteng, 0184, South Africa
Synexus SA - Roodepoort Medicross Clinical Research Centre
Roodeport, Gauteng, 1724, South Africa
Seoul National University Hospital
Seoul, 110-744, South Korea
Ladulaas Kliniken
Borås, 506 30, Sweden
CTC, Gothia Forum, Sahlgrenska Universitetssjukhus
Gothenburg, 413 45, Sweden
Probare
Lund, 222 22, Sweden
Pharmasite
Malmo, 211 52, Sweden
Bragee Medect AB
Stockholm, 115 26, Sweden
Related Publications (1)
Markman J, Resnick M, Greenberg S, Katz N, Yang R, Scavone J, Whalen E, Gregorian G, Parsons B, Knapp L. Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial. J Neurol. 2018 Dec;265(12):2815-2824. doi: 10.1007/s00415-018-9063-9. Epub 2018 Sep 21.
PMID: 30242745DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer Clinical Trials.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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2012
First Posted
October 5, 2012
Study Start
October 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
January 28, 2021
Results First Posted
June 7, 2017
Record last verified: 2017-04