Clinical trial NCT01701362: Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropathic Pain
Keywords: post-traumatic peripheral neuropathic pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-10-05
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Baseline Mean Pain Score
timeFrame: Baseline
measure: Change From Baseline to Week 15 in Weekly Mean Pain Score
timeFrame: up to Week 15
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC) at Week 15
timeFrame: Week 15
measure: Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)
timeFrame: up to Week 15
measure: Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])
timeFrame: Week 15
measure: Change From Baseline in Pain Interference Index (BPI-sf)
timeFrame: Week 15
measure: Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores
timeFrame: Week 15
measure: Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
timeFrame: Baseline
measure: Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
timeFrame: Week 15
measure: Percentage of Participants in MOS-SS With Optimal Sleep Status.
timeFrame: Week 15
measure: Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.
timeFrame: Week 15
measure: Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%
timeFrame: Week 15
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Tennesse Valley Pain Consultants
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Neuromuscular Research Center
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Centers, LLC
state: Arizona
city: Artesia
country: United States
facility: Advanced Rx Clinical Research
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Irvine
country: United States
facility: NervePro Medical Corp.
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: La Jolla
country: United States
facility: Clinical and Translational Research Institute
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Laguna Hills
country: United States
facility: South Orange County Surgical Medical Group
state: California
city: Lakewood
country: United States
facility: Center For United Research, Inc.
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: USC I.D.S. Pharmacy
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Roseville
country: United States
facility: Allied Clinical Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Boulder
country: United States
facility: Colorado Clinic
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research Inc.
state: Colorado
city: Fort Collins
country: United States
facility: St. Luke's Medical Clinic
state: Colorado
city: Washington
country: United States
facility: Investigational Drug Services, The George Washington University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: The George Washington University Medical Center (Department of Neurology)
state: District of Columbia
city: Washington
country: United States
facility: The George Washington University Medical Center
state: District of Columbia
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
state: Florida
city: Clearwater
country: United States
facility: Advance Medical Research
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Hialeah
country: United States
facility: Aga Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab & Research Center
state: Florida
city: Hialeah
country: United States
facility: Research in Miami, Inc.
state: Florida
city: Homestead
country: United States
facility: Homestead Medical Research , Inc.
state: Florida
city: Miami Gardens
country: United States
facility: AMPM Research Clinic
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Florida International Research Center
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: A-One Family Practice
state: Florida
city: Ormond Beach
country: United States
facility: Aba Family Medicine, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Ribo Research, LLC dba Peninsula Resarch
state: Florida
city: Royal Palm Beach
country: United States
facility: Comprehensive Pain Care of South Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Pain Medicine Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Advanced Internal Medicine, PC
state: Georgia
city: Stockbridge
country: United States
facility: Research 1 Clinical Research Network, Inc. (Administrative Office Only)
state: Georgia
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Chicago
country: United States
facility: Chicago Anesthesia Associates
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Bone & Joint Clinic
state: Kansas
city: Edgewood
country: United States
facility: Otri-Med Corporation
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Lake Charles
country: United States
facility: Centex Studies, Inc
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Rochester
country: United States
facility: University of Rochester, Translational Pain Research
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Bellevue
country: United States
facility: Northern Ohio Neurosciences, LLC
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Toledo
country: United States
facility: Northwest Ohio Research Center, LLC
state: Ohio
city: Toledo
country: United States
facility: Robert L Kalb, M.D, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Cor Clinical Research, Llc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network, Inc.
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management, P.C.
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Lifetree
state: Pennsylvania
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials, Inc.
state: South Carolina
city: Columbia
country: United States
facility: TLM Medical Services, LLC
state: South Carolina
city: Greenville
country: United States
facility: Piedmont Comprehensive Pain Management Group, LLC
state: South Carolina
city: Greenville
country: United States
facility: Pharmacum Biomedical Research
state: South Carolina
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Dallas
country: United States
facility: Dallas Pain Consultants
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, L. P.
state: Texas
city: Houston
country: United States
facility: Abigail R. Neiman, MD, PA
state: Texas
city: Houston
country: United States
facility: Agadadash Kuliev, MD, PA
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc. Research Center
state: Texas
city: Houston
country: United States
facility: Medstar Clinical Research Associates
state: Texas
city: Richardson
country: United States
facility: ClinRx Research, LLC
state: Texas
city: San Antonio
country: United States
facility: DCT - Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Sealy
country: United States
facility: Sealy Urgent Care Center and Medical Clinic
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc./Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewish Research, Inc./Foothill Family Clinic South
state: Utah
city: Arlington
country: United States
facility: Integrated Neurology Services , PLLC
state: Virginia
city: Arlington
country: United States
facility: IntegraTrials, LLC
state: Virginia
city: Bellevue
country: United States
facility: Washington Center for Pain Management LLC
state: Washington
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Edmonds
country: United States
facility: Washington Center for Pain Management LLC
state: Washington
city: Everett
country: United States
facility: Washington Center for Pain Management LLC
state: Washington
city: Renton
country: United States
facility: Washington Center for Pain Management LLC
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Blagoevgrad
country: Bulgaria
facility: MHAT Puls AD
city: Pleven
country: Bulgaria
facility: MHAT "Avis Medika"
city: Pleven
country: Bulgaria
facility: MHAT "Sv.Pantaleymon"
city: Sevlievo
country: Bulgaria
facility: DCC Akta Medika Ltd.
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska
city: Sofia
country: Bulgaria
facility: DCC "Sveta Anna"EOOD
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: London
country: Canada
facility: NRK Medical Research Clinic (Adminstrative Office Only)
state: Ontario
city: London
country: Canada
facility: NRK Medical Research Clinic
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Sisak
country: Croatia
facility: General Hospital "dr. Ivo Pedisic"
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
state: Niedersachsen
city: Böhlen
country: Germany
facility: Praxis für Spezielle Schmerztherapie und Palliativmedizin
state: Sachsen
city: Leipzig
country: Germany
facility: medamed GmbH Studienambulanz
state: Sachsen
city: Kiel-Kronshagen
country: Germany
facility: pro scientia med im MARE Klinikum
state: Schleswig-holstein
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Synexus Clinical Research GmbH
city: Bochum
country: Germany
facility: Synexus Clinical Research GmbH
city: Frankfurt
country: Germany
facility: Synexus Clinical Research GmbH
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Hamburg
country: Germany
facility: Gemeinschaftspraxis für Schmerz- und Psychotherapie
city: Leipzig
country: Germany
facility: Synexus Clinical Research GmbH
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Budapest
country: Hungary
facility: UNO Medical Trials Kft
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Gdansk
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z.o.o.
city: Gdynia
country: Poland
facility: "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
city: Katowice
country: Poland
facility: "Synexus Polska" Sp. z o.o. Oddzial W Katowicach
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Swidnik
country: Poland
facility: NZOZ IGNIS dr n. med. Alicja Lobinska
city: Warszawa
country: Poland
facility: "SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE
city: Wroclaw
country: Poland
facility: "SYNEXUS POLSKA" Sp. z o.o. Odzial we Wroclawiu
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine, CAIMED Center
city: Bucuresti
country: Romania
facility: Centrul Medical Sana
city: Campulung Muscel
country: Romania
facility: Clubul Sanatatii SRL
city: Craiova
country: Romania
facility: Spitalul Clinic de Neuropsihiatrie Craiova
city: Oradea
country: Romania
facility: Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea,Sectia Neurologie I
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu,Sectia Neurologie
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu-Mures , Sectia Neurologie II
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Centre
state: FREE State
city: Pretoria
country: South Africa
facility: Synexus SA - Stanza Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Synexus SA - Watermeyer Clinical Research Centre
state: Gauteng
city: Roodeport
country: South Africa
facility: Synexus SA - Roodepoort Medicross Clinical Research Centre
state: Gauteng
city: Boras
country: Sweden
facility: Ladulaas Kliniken
city: Göteborg
country: Sweden
facility: CTC, Gothia Forum, Sahlgrenska Universitetssjukhus
city: Lund
country: Sweden
facility: Probare
city: Malmö
country: Sweden
facility: Pharmasite
city: Stockholm
country: Sweden
facility: Bragee Medect AB
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.