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

Sponsors

Lead Sponsor: Pfizer

Source Pfizer
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.

Overall Status Completed
Start Date October 2012
Completion Date August 2015
Primary Completion Date August 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Baseline Mean Pain Score Baseline
Change From Baseline to Week 15 in Weekly Mean Pain Score up to Week 15
Secondary Outcome
Measure Time Frame
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
Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. Baseline
Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. Week 15
Percentage of Participants in MOS-SS With Optimal Sleep Status. Week 15
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. Week 15
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% Week 15
Enrollment 542
Condition
Intervention

Intervention Type: Drug

Intervention Name: pregabalin

Description: capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization

Arm Group Label: pregabalin

Other Name: Lyrica, PD-144723

Intervention Type: Drug

Intervention Name: placebo

Description: capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization

Arm Group Label: placebo

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility:
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
AMPM Research Clinic | Miami Gardens, Florida, 33169, 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
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. | Saint 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, 2600, Denmark
Klinische Forschung Hannover-Mitte GmbH | Hannover, Niedersachsen, 30159, Germany
Praxis für Spezielle Schmerztherapie und Palliativmedizin | Böhlen, Sachsen, 04564, Germany
medamed GmbH Studienambulanz | Leipzig, Sachsen, 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
Seoul National University Hospital | Seoul, 110-744, Korea, Republic of
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 | Swidnik, 21-040, Poland
"SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE | Warszawa, 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 | Bucuresti, 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 | Targu Mures, 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
Ladulaas Kliniken | Boras, 506 30, Sweden
CTC, Gothia Forum, Sahlgrenska Universitetssjukhus | Göteborg, 413 45, Sweden
Probare | Lund, 222 22, Sweden
Pharmasite | Malmö, 211 52, Sweden
Bragee Medect AB | Stockholm, 115 26, Sweden
Location Countries

Bulgaria

Canada

Croatia

Denmark

Germany

Hungary

Korea, Republic of

Poland

Puerto Rico

Romania

South Africa

Sweden

United States

Verification Date

April 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: pregabalin

Type: Active Comparator

Label: placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov