Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
Launched by PFIZER'S UPJOHN HAS MERGED WITH MYLAN TO FORM VIATRIS INC. · Oct 3, 2012
Trial Information
Current as of April 30, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About Pfizer's Upjohn Has Merged With Mylan To Form Viatris Inc.
Viatris Inc. is a global healthcare company formed from the merger of Pfizer's Upjohn division and Mylan, dedicated to providing access to high-quality medicines, including generics and specialty pharmaceuticals. With a strong commitment to innovation and patient-centric solutions, Viatris leverages a diverse portfolio and extensive global reach to address the evolving healthcare needs of patients worldwide. The company aims to create sustainable healthcare solutions by combining expertise in pharmaceutical development, manufacturing, and distribution, ultimately enhancing patient outcomes and improving overall health systems.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Boston, Massachusetts, United States
Irvine, California, United States
Walnut Creek, California, United States
Phoenix, Arizona, United States
Chicago, Illinois, United States
Seoul, , Korea, Republic Of
Clearwater, Florida, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Salt Lake City, Utah, United States
Lexington, Kentucky, United States
Wichita Falls, Texas, United States
Kettering, Ohio, United States
Las Vegas, Nevada, United States
Glostrup, , Denmark
Washington, District Of Columbia, United States
Seattle, Washington, United States
Ann Arbor, Michigan, United States
Omaha, Nebraska, United States
Boynton Beach, Florida, United States
Miami Gardens, Florida, United States
Orlando, Florida, United States
Winston Salem, North Carolina, United States
San Antonio, Texas, United States
Omaha, Nebraska, United States
Sacramento, California, United States
Sarasota, Florida, United States
Oceanside, California, United States
Bucuresti, , Romania
Hialeah, Florida, United States
Goodyear, Arizona, United States
Arlington, Virginia, United States
Miskolc, , Hungary
Portland, Oregon, United States
Wildomar, California, United States
Phoenix, Arizona, United States
Bellevue, Washington, United States
Saint Louis, Missouri, United States
Los Gatos, California, United States
Miami, Florida, United States
Hamburg, , Germany
Laguna Hills, California, United States
Marietta, Georgia, United States
Schwerin, , Germany
Miami, Florida, United States
Columbia, South Carolina, United States
Richardson, Texas, United States
Miami, Florida, United States
Budapest, , Hungary
Berlin, , Germany
Charleston, South Carolina, United States
Krakow, , Poland
Glendale, California, United States
Philadelphia, Pennsylvania, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Hialeah, Florida, United States
Royal Palm Beach, Florida, United States
Kiel Kronshagen, Schleswig Holstein, Germany
Charlotte, North Carolina, United States
Berlin, , Germany
Bochum, , Germany
Leipzig, , Germany
Lund, , Sweden
Columbus, Georgia, United States
Sarnia, Ontario, Canada
Atlanta, Georgia, United States
Altoona, Pennsylvania, United States
Knoxville, Tennessee, United States
Tampa, Florida, United States
Sealy, Texas, United States
Brampton, Ontario, Canada
La Jolla, California, United States
Laguna Hills, California, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Artesia, California, United States
Irvine, California, United States
Lakewood, California, United States
Los Angeles, California, United States
Roseville, California, United States
Boulder, Colorado, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Clearwater, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
Ormond Beach, Florida, United States
Ormond Beach, Florida, United States
Stockbridge, Georgia, United States
Stockbridge, Georgia, United States
Chicago, Illinois, United States
Overland Park, Kansas, United States
Edgewood, Kentucky, United States
Lake Charles, Louisiana, United States
Rochester, New York, United States
Bellevue, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Arlington, Virginia, United States
Bellevue, Washington, United States
Edmonds, Washington, United States
Everett, Washington, United States
Renton, Washington, United States
Blagoevgrad, , Bulgaria
Pleven, , Bulgaria
Pleven, , Bulgaria
Sevlievo, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
London, Ontario, Canada
London, Ontario, Canada
Sisak, , Croatia
Hannover, Niedersachsen, Germany
Böhlen, Sachsen, Germany
Leipzig, Sachsen, Germany
Frankfurt, , Germany
Hamburg, , Germany
Budapest, , Hungary
Gdansk, , Poland
Gdynia, , Poland
Katowice, , Poland
Swidnik, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Ponce, , Puerto Rico
Campulung Muscel, , Romania
Craiova, , Romania
Oradea, , Romania
Sibiu, , Romania
Targu Mures, , Romania
Welkom, Free State, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Roodeport, Gauteng, South Africa
Boras, , Sweden
Göteborg, , Sweden
Malmö, , Sweden
Stockholm, , Sweden
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials