Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

Phase 3

Completed

Conditions: Neuropathic Pain

Interventions: Drug: placebo
Drug: pregabalin

Registration Number: NCT01701362

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

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 542

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
pregabalin	pregabalin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 15 in Weekly Mean Pain Score	up to Week 15	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.
Baseline Mean Pain Score	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC) at Week 15	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.
Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores	Week 15	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.
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.	Week 15	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.
Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)	up to Week 15	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.
Change From Baseline in Pain Interference Index (BPI-sf)	Week 15	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.
Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.	Baseline	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.
Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])	Week 15	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.
Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.	Week 15	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.
Percentage of Participants in MOS-SS With Optimal Sleep Status.	Week 15	MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%	Week 15	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.

Trial Locations

Locations (149): Aggarwal and Associates Limited
🇨🇦
Brampton, Ontario, Canada
Chicago Anesthesia Associates
🇺🇸
Chicago, Illinois, United States
Rehabilitation Institute of Chicago
🇺🇸
Chicago, Illinois, United States
St. Luke's Medical Clinic
🇺🇸
Fort Collins, Colorado, United States
Tennesse Valley Pain Consultants
🇺🇸
Huntsville, Alabama, United States
Behavioral Research Specialists, LLC
🇺🇸
Glendale, California, United States
Advanced Rx Clinical Research
🇺🇸
Artesia, California, United States
NervePro Medical Corp.
🇺🇸
Irvine, California, United States
Alliance Research Centers
🇺🇸
Laguna Hills, California, United States
Clinical and Translational Research Institute
🇺🇸
La Jolla, California, United States
Center For United Research, Inc.
🇺🇸
Lakewood, California, United States
South Orange County Surgical Medical Group
🇺🇸
Laguna Hills, California, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Samaritan Center for Medical Research
🇺🇸
Los Gatos, California, United States
USC I.D.S. Pharmacy
🇺🇸
Los Angeles, California, United States
North County Clinical Research
🇺🇸
Oceanside, California, United States
Allied Clinical Research
🇺🇸
Roseville, California, United States
Diablo Clinical Research, Inc.
🇺🇸
Walnut Creek, California, United States
Elite Clinical Trials, Inc.
🇺🇸
Wildomar, California, United States
Colorado Clinic
🇺🇸
Boulder, Colorado, United States
Orthopedic Research Institute
🇺🇸
Boynton Beach, Florida, United States
Advance Medical Research
🇺🇸
Clearwater, Florida, United States
Innovative Research of West Florida
🇺🇸
Clearwater, Florida, United States
Health Care Family Rehab & Research Center
🇺🇸
Hialeah, Florida, United States
Research in Miami, Inc.
🇺🇸
Hialeah, Florida, United States
Homestead Medical Research , Inc.
🇺🇸
Homestead, Florida, United States
AMPM Research Clinic
🇺🇸
Miami Gardens, Florida, United States
A-One Family Practice
🇺🇸
Ormond Beach, Florida, United States
Aba Family Medicine, LLC
🇺🇸
Ormond Beach, Florida, United States
Ribo Research, LLC dba Peninsula Resarch
🇺🇸
Ormond Beach, Florida, United States
Sarasota Pain Medicine Research
🇺🇸
Sarasota, Florida, United States
Comprehensive Pain Care of South Florida
🇺🇸
Royal Palm Beach, Florida, United States
Atlanta Center for Medical Research
🇺🇸
Atlanta, Georgia, United States
Columbus Regional Research Institute
🇺🇸
Columbus, Georgia, United States
Georgia Institute for Clinical Research, LLC
🇺🇸
Marietta, Georgia, United States
Advanced Internal Medicine, PC
🇺🇸
Stockbridge, Georgia, United States
Kansas City Bone & Joint Clinic
🇺🇸
Overland Park, Kansas, United States
Otri-Med Corporation
🇺🇸
Edgewood, Kentucky, United States
Medex Healthcare Research, Inc.
🇺🇸
Saint Louis, Missouri, United States
PMG Research of Charlotte
🇺🇸
Charlotte, North Carolina, United States
Northern Ohio Neurosciences, LLC
🇺🇸
Bellevue, Ohio, United States
Northwest Ohio Research Center, LLC
🇺🇸
Toledo, Ohio, United States
Wells Institute for Health Awareness
🇺🇸
Kettering, Ohio, United States
Robert L Kalb, M.D, Inc
🇺🇸
Toledo, Ohio, United States
CRI Lifetree
🇺🇸
Philadelphia, Pennsylvania, United States
TLM Medical Services, LLC
🇺🇸
Columbia, South Carolina, United States
Piedmont Comprehensive Pain Management Group, LLC
🇺🇸
Greenville, South Carolina, United States
Dallas Pain Consultants
🇺🇸
Dallas, Texas, United States
Abigail R. Neiman, MD, PA
🇺🇸
Houston, Texas, United States
FutureSearch Trials of Dallas, L. P.
🇺🇸
Dallas, Texas, United States
Agadadash Kuliev, MD, PA
🇺🇸
Houston, Texas, United States
Medstar Clinical Research Associates
🇺🇸
Houston, Texas, United States
ClinRx Research, LLC
🇺🇸
Richardson, Texas, United States
Grayline Clinical Drug Trials
🇺🇸
Wichita Falls, Texas, United States
Sealy Urgent Care Center and Medical Clinic
🇺🇸
Sealy, Texas, United States
Integrated Neurology Services , PLLC
🇺🇸
Arlington, Virginia, United States
IntegraTrials, LLC
🇺🇸
Arlington, Virginia, United States
Northwest Clinical Research Center
🇺🇸
Bellevue, Washington, United States
Washington Center for Pain Management LLC
🇺🇸
Renton, Washington, United States
Summit Research Network (Seattle) LLC
🇺🇸
Seattle, Washington, United States
London Road Diagnostic Clinic and Medical Centre
🇨🇦
Sarnia, Ontario, Canada
Klinische Forschung Hannover-Mitte GmbH
🇩🇪
Hannover, Niedersachsen, Germany
Praxis für Spezielle Schmerztherapie und Palliativmedizin
🇩🇪
Böhlen, Sachsen, Germany
medamed GmbH Studienambulanz
🇩🇪
Leipzig, Sachsen, Germany
pro scientia med im MARE Klinikum
🇩🇪
Kiel-Kronshagen, Schleswig-holstein, Germany
Klinische Forschung Berlin-Mitte GmbH
🇩🇪
Berlin, Germany
Klinische Forschung Hamburg GmbH
🇩🇪
Hamburg, Germany
Gemeinschaftspraxis für Schmerz- und Psychotherapie
🇩🇪
Hamburg, Germany
Synexus Magyarorszag Kft.
🇭🇺
Budapest, Hungary
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
"SYNEXUS POLSKA" Sp. z o.o. Odzial we Wroclawiu
🇵🇱
Wroclaw, Poland
Centrul Medical Sana
🇷🇴
Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta Sibiu,Sectia Neurologie
🇷🇴
Sibiu, Romania
Ladulaas Kliniken
🇸🇪
Boras, Sweden
Synexus SA - Stanza Clinical Research Centre
🇿🇦
Pretoria, Gauteng, South Africa
Synexus SA - Roodepoort Medicross Clinical Research Centre
🇿🇦
Roodeport, Gauteng, South Africa
Synexus SA - Watermeyer Clinical Research Centre
🇿🇦
Pretoria, Gauteng, South Africa
CTC, Gothia Forum, Sahlgrenska Universitetssjukhus
🇸🇪
Göteborg, Sweden
Probare
🇸🇪
Lund, Sweden
Pharmasite
🇸🇪
Malmö, Sweden
Bragee Medect AB
🇸🇪
Stockholm, Sweden
Glostrup Hospital
🇩🇰
Glostrup, Denmark
HOPE Research Institute
🇺🇸
Phoenix, Arizona, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Mountain View Clinical Research Inc.
🇺🇸
Denver, Colorado, United States
San Marcus Research Clinic, Inc.
🇺🇸
Miami, Florida, United States
Advanced Pharma CR, LLC
🇺🇸
Miami, Florida, United States
Florida International Research Center
🇺🇸
Miami, Florida, United States
Kendall South Medical Center, Inc.
🇺🇸
Miami, Florida, United States
Cor Clinical Research, Llc
🇺🇸
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Summit Research Network, Inc.
🇺🇸
Portland, Oregon, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
🇺🇸
San Antonio, Texas, United States
Lifetree Clinical Research
🇺🇸
Salt Lake City, Utah, United States
J. Lewis Research, Inc./Foothill Family Clinic
🇺🇸
Salt Lake City, Utah, United States
MHAT "Sv.Pantaleymon"
🇧🇬
Pleven, Bulgaria
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
🇭🇺
Miskolc, Hungary
Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z.o.o.
🇵🇱
Gdansk, Poland
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
🇵🇱
Gdynia, Poland
Malopolskie Centrum Medyczne S.C.
🇵🇱
Krakow, Poland
Pharmacum Biomedical Research
🇺🇸
Greenville, South Carolina, United States
The Pain Center of Arizona
🇺🇸
Phoenix, Arizona, United States
Dedicated Clinical Research
🇺🇸
Goodyear, Arizona, United States
Neuromuscular Research Center
🇺🇸
Phoenix, Arizona, United States
Advanced Biomedical Research of America
🇺🇸
Las Vegas, Nevada, United States
Quality of Life Medical & Research Centers, LLC
🇺🇸
Tucson, Arizona, United States
Elite Clinical Studies, LLC
🇺🇸
Phoenix, Arizona, United States
UNO Medical Trials Kft
🇭🇺
Budapest, Hungary
The George Washington University Medical Center
🇺🇸
Washington, District of Columbia, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
"Synexus Polska" Sp. z o.o. Oddzial W Katowicach
🇵🇱
Katowice, Poland
Clubul Sanatatii SRL
🇷🇴
Campulung Muscel, Romania
Spitalul Clinic de Neuropsihiatrie Craiova
🇷🇴
Craiova, Romania
Centex Studies, Inc
🇺🇸
Lake Charles, Louisiana, United States
Welkom Clinical Trial Centre
🇿🇦
Welkom, FREE State, South Africa
MHAT Puls AD
🇧🇬
Blagoevgrad, Bulgaria
MHAT "Avis Medika"
🇧🇬
Pleven, Bulgaria
DCC Akta Medika Ltd.
🇧🇬
Sevlievo, Bulgaria
DCC "Sveta Anna"EOOD
🇧🇬
Sofia, Bulgaria
General Hospital "dr. Ivo Pedisic"
🇭🇷
Sisak, Croatia
Ponce School of Medicine, CAIMED Center
🇵🇷
Ponce, Puerto Rico
Investigational Drug Services, The George Washington University Medical Center
🇺🇸
Washington, District of Columbia, United States
The George Washington University Medical Center (Department of Neurology)
🇺🇸
Washington, District of Columbia, United States
J. Lewish Research, Inc./Foothill Family Clinic South
🇺🇸
Salt Lake City, Utah, United States
New Phase Research and Development
🇺🇸
Knoxville, Tennessee, United States
UMHAT Aleksandrovska
🇧🇬
Sofia, Bulgaria
NZOZ IGNIS dr n. med. Alicja Lobinska
🇵🇱
Swidnik, Poland
"SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE
🇵🇱
Warszawa, Poland
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea,Sectia Neurologie I
🇷🇴
Oradea, Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures , Sectia Neurologie II
🇷🇴
Targu Mures, Romania
Meridien Research
🇺🇸
Tampa, Florida, United States
Quality Clinical Research, Inc.
🇺🇸
Omaha, Nebraska, United States
Heartland Clinical Research, Inc.
🇺🇸
Omaha, Nebraska, United States
NRK Medical Research Clinic (Adminstrative Office Only)
🇨🇦
London, Ontario, Canada
NRK Medical Research Clinic
🇨🇦
London, Ontario, Canada
Synexus Clinical Research GmbH
🇩🇪
Leipzig, Germany
Klinische Forschung Schwerin GmbH
🇩🇪
Schwerin, Germany
Aga Clinical Trials
🇺🇸
Hialeah, Florida, United States
Research 1 Clinical Research Network, Inc. (Administrative Office Only)
🇺🇸
Stockbridge, Georgia, United States
Allegheny Pain Management, P.C.
🇺🇸
Altoona, Pennsylvania, United States
Biopharma Informatic Inc. Research Center
🇺🇸
Houston, Texas, United States
University of California, Irvine
🇺🇸
Irvine, California, United States
Northern California Research
🇺🇸
Sacramento, California, United States
Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Michigan Head Pain and Neurological Institute
🇺🇸
Ann Arbor, Michigan, United States
Pharmacorp Clinical Trials, Inc.
🇺🇸
Charleston, South Carolina, United States
PMG Research of Winston-Salem
🇺🇸
Winston-Salem, North Carolina, United States
Central Kentucky Research Associates, Inc.
🇺🇸
Lexington, Kentucky, United States
University of Rochester, Translational Pain Research
🇺🇸
Rochester, New York, United States