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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: pregabalin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 542
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • MHAT Puls AD
  • Pleven, Bulgaria, 5800
    • MHAT "Avis Medika"
  • Pleven, Bulgaria, 5800
    • MHAT "Sv.Pantaleymon"
  • Sevlievo, Bulgaria, 5400
    • DCC Akta Medika Ltd.
  • Sofia, Bulgaria, 1431
    • UMHAT Aleksandrovska
  • Sofia, Bulgaria, 1709
    • DCC "Sveta Anna"EOOD
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • London, Ontario, Canada, N6H 4P2
      • NRK Medical Research Clinic (Adminstrative Office Only)
    • London, Ontario, Canada, N6H 4P2
      • NRK Medical Research Clinic
    • Sarnia, Ontario, Canada, N7T 4X3
      • London Road Diagnostic Clinic and Medical Centre
• Croatia
  • Sisak, Croatia, 44000
    • General Hospital "dr. Ivo Pedisic"
• Denmark
  • Glostrup, Denmark, 2600
    • Glostrup Hospital
• Germany
  • Berlin, Germany, 10117
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany, 12627
    • Synexus Clinical Research GmbH
  • Bochum, Germany, 44787
    • Synexus Clinical Research GmbH
  • Frankfurt, Germany, 60596
    • Synexus Clinical Research GmbH
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Hamburg, Germany, 22767
    • Gemeinschaftspraxis für Schmerz- und Psychotherapie
  • Leipzig, Germany, 04103
    • Synexus Clinical Research GmbH
  • Schwerin, Germany, 19055
    • Klinische forschung Schwerin GmbH
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
      • Klinische Forschung Hannover-Mitte GmbH
  • Sachsen
    • Böhlen, Sachsen, Germany, 04564
      • Praxis für Spezielle Schmerztherapie und Palliativmedizin
    • Leipzig, Sachsen, Germany, 04109
      • Medamed GmbH Studienambulanz
  • Schleswig-holstein
    • Kiel-Kronshagen, Schleswig-holstein, Germany, 24119
      • pro scientia med im MARE Klinikum
• Hungary
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft.
  • Budapest, Hungary, 1135
    • Uno Medical Trials Kft
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
• Poland
  • Gdansk, Poland, 80-286
    • Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z.o.o.
  • Gdynia, Poland, 81-384
    • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
  • Katowice, Poland, 40-040
    • "Synexus Polska" Sp. z o.o. Oddzial W Katowicach
  • Krakow, Poland, 30-510
    • Malopolskie Centrum Medyczne s.c.
  • Swidnik, Poland, 21-040
    • NZOZ IGNIS dr n. med. Alicja Lobinska
  • Warszawa, Poland, 01-192
    • "SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE
  • Wroclaw, Poland, 50-088
    • "SYNEXUS POLSKA" Sp. z o.o. Odzial we Wroclawiu
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine, CAIMED Center
• Romania
  • Bucuresti, Romania, 011025
    • Centrul Medical Sana
  • Campulung Muscel, Romania, 115100
    • Clubul Sanatatii SRL
  • Craiova, Romania, 200473
    • Spitalul Clinic de Neuropsihiatrie Craiova
  • Oradea, Romania, 410154
    • Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea,Sectia Neurologie I
  • Sibiu, Romania, 550166
    • Spitalul Clinic Judetean de Urgenta Sibiu,Sectia Neurologie
  • Targu Mures, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Targu-Mures , Sectia Neurologie II
• South Africa
  • FREE State
    • Welkom, FREE State, South Africa, 9460
      • Welkom Clinical Trial Centre
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0122
      • Synexus SA - Stanza Clinical Research Centre
    • Pretoria, Gauteng, South Africa, 0184
      • Synexus SA - Watermeyer Clinical Research Centre
    • Roodeport, Gauteng, South Africa, 1724
      • Synexus SA - Roodepoort Medicross Clinical Research Centre
• Sweden
  • Boras, Sweden, 506 30
    • Ladulaas Kliniken
  • Göteborg, Sweden, 413 45
    • CTC, Gothia Forum, Sahlgrenska Universitetssjukhus
  • Lund, Sweden, 222 22
    • ProbarE
  • Malmö, Sweden, 211 52
    • PharmaSite
  • Stockholm, Sweden, 115 26
    • Bragee Medect AB
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Tennesse Valley Pain Consultants
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85018
      • HOPE Research Institute
    • Phoenix, Arizona, United States, 85018
      • The Pain Center of Arizona
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies, LLC
    • Phoenix, Arizona, United States, 85027
      • The Pain Center of Arizona
    • Phoenix, Arizona, United States, 85028
      • Neuromuscular Research Center
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical & Research Centers, LLC
  • California
    • Artesia, California, United States, 90701
      • Advanced Rx Clinical Research
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Irvine, California, United States, 92697
      • University of California, Irvine
    • Irvine, California, United States, 92618
      • NervePro Medical Corp.
    • La Jolla, California, United States, 92093
      • Clinical and Translational Research Institute
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Laguna Hills, California, United States, 92653
      • South Orange County Surgical Medical Group
    • Lakewood, California, United States, 90805
      • Center For United Research, Inc.
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90089
      • USC I.D.S. Pharmacy
    • Los Gatos, California, United States, 95032
      • Samaritan Center for Medical Research
    • Oceanside, California, United States, 92056
      • North County Clinical Research
    • Roseville, California, United States, 95661
      • Allied Clinical Research
    • Sacramento, California, United States, 95821
      • Northern California Research
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
    • Wildomar, California, United States, 92595
      • Elite Clinical Trials, Inc.
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Colorado Clinic
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research Inc.
    • Fort Collins, Colorado, United States, 80525
      • St. Luke's Medical Clinic
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University Medical Center
    • Washington, District of Columbia, United States, 20037
      • Investigational Drug Services, The George Washington University Medical Center
    • Washington, District of Columbia, United States, 20037
      • The George Washington University Medical Center (Department of Neurology)
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Orthopedic Research Institute
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida
    • Clearwater, Florida, United States, 33756
      • Advance Medical Research
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trials
    • Hialeah, Florida, United States, 33012
      • Health Care Family Rehab & Research Center
    • Hialeah, Florida, United States, 33013
      • Research In Miami, Inc.
    • Homestead, Florida, United States, 33030
      • Homestead Medical Research , Inc.
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic, Inc.
    • Miami, Florida, United States, 33173
      • Florida International Research Center
    • Miami, Florida, United States, 33185
      • Kendall South Medical Center, Inc.
    • Miami, Florida, United States, 33136
      • Advanced Pharma CR, LLC
    • Miami Gardens, Florida, United States, 33169
      • AMPM Research Clinic
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Ormond Beach, Florida, United States, 32174
      • Aba Family Medicine, LLC
    • Ormond Beach, Florida, United States, 32174
      • A-One Family Practice
    • Ormond Beach, Florida, United States, 32174
      • Ribo Research, LLC dba Peninsula Resarch
    • Royal Palm Beach, Florida, United States, 33411
      • Comprehensive Pain Care of South Florida
    • Sarasota, Florida, United States, 34238
      • Sarasota Pain Medicine Research
    • Tampa, Florida, United States, 33634
      • Meridien Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research, LLC
    • Stockbridge, Georgia, United States, 30281
      • Advanced Internal Medicine, PC
    • Stockbridge, Georgia, United States, 30281
      • Research 1 Clinical Research Network, Inc. (Administrative Office Only)
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago
    • Chicago, Illinois, United States, 60657
      • Chicago Anesthesia Associates
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Bone & Joint Clinic
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Otri-Med Corporation
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates, Inc.
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Centex Studies, Inc
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurological Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Medex Healthcare Research, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Advanced Biomedical Research of America
  • New York
    • Rochester, New York, United States, 14618
      • University of Rochester, Translational Pain Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
  • Ohio
    • Bellevue, Ohio, United States, 44811
      • Northern Ohio Neurosciences, LLC
    • Kettering, Ohio, United States, 45429
      • Wells Institute for Health Awareness
    • Toledo, Ohio, United States, 43623
      • Northwest Ohio Research Center, LLC
    • Toledo, Ohio, United States, 43623
      • Robert L Kalb, M.D, Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network, Inc.
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Allegheny Pain Management, P.C.
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Lifetree
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Pharmacorp Clinical Trials, Inc.
    • Columbia, South Carolina, United States, 29204
      • TLM Medical Services, LLC
    • Greenville, South Carolina, United States, 29601
      • Piedmont Comprehensive Pain Management Group, LLC
    • Greenville, South Carolina, United States, 29605
      • Pharmacum Biomedical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37919
      • New Phase Research and Development
  • Texas
    • Dallas, Texas, United States, 75203
      • Dallas Pain Consultants
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, L. P.
    • Houston, Texas, United States, 77024
      • Abigail R. Neiman, MD, PA
    • Houston, Texas, United States, 77043
      • Agadadash Kuliev, MD, PA
    • Houston, Texas, United States, 77043
      • Biopharma Informatic Inc. Research Center
    • Houston, Texas, United States, 77083
      • Medstar Clinical Research Associates
    • Richardson, Texas, United States, 75080
      • ClinRx Research, LLC
    • San Antonio, Texas, United States, 78258
      • DCT - Stone Oak, LLC dba Discovery Clinical Trials
    • Sealy, Texas, United States, 77474
      • Sealy Urgent Care Center and Medical Clinic
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc./Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84106
      • Lifetree Clinical Research
    • Salt Lake City, Utah, United States, 84121
      • J. Lewish Research, Inc./Foothill Family Clinic South
  • Virginia
    • Arlington, Virginia, United States, 22205
      • IntegraTrials, LLC
    • Arlington, Virginia, United States, 22205
      • Integrated Neurology Services , PLLC
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Bellevue, Washington, United States, 98004
      • Washington Center for Pain Management LLC
    • Edmonds, Washington, United States, 98026
      • Washington Center for Pain Management LLC
    • Everett, Washington, United States, 98201
      • Washington Center for Pain Management LLC
    • Renton, Washington, United States, 98055
      • Washington Center for Pain Management LLC
    • Seattle, Washington, United States, 98104
      • Summit Research Network (Seattle) Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: placebo; capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
ACTIVE_COMPARATOR: pregabalin	Drug: pregabalin; capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization; Other Names: Lyrica, PD-144723

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGIC) at Week 15	A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.	Week 15
Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)	This is an 11-point NRS ranging from 0 ("pain does not interfere with sleep") to 10 ("pain completely interferes with sleep" [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context. Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings. "Overall" is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.	up to Week 15
Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])	A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.	Week 15
Change From Baseline in Pain Interference Index (BPI-sf)	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes). The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.	Week 15
Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores	A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.	Week 15
Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.	MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores. Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement. Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement. Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.	Baseline
Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.	MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores. Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement. Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement. Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.	Week 15
Percentage of Participants in MOS-SS With Optimal Sleep Status.	MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.	Week 15
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.	Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.	Week 15
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%	Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.	Week 15

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: October 3, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (ESTIMATE): October 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: post-traumatic peripheral neuropathic pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081279; 2012-003304-12 (EUDRACT_NUMBER)