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

Completed · Phase 3 · Has a placebo group

Conditions studied: Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT01701362

Run by

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

People needed

542

Starts

2012-10-01

Expected to finish

2015-08-01

Last updated by the study team

2021-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dedicated Clinical Research — Goodyear, Arizona, United States
• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Neuromuscular Research Center — Phoenix, Arizona, United States
• Quality of Life Medical & Research Centers, LLC — Tucson, Arizona, United States
• Advanced Rx Clinical Research — Artesia, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• NervePro Medical Corp. — Irvine, California, United States
• University of California, Irvine — Irvine, California, United States
• Clinical and Translational Research Institute — La Jolla, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• South Orange County Surgical Medical Group — Laguna Hills, California, United States
• Center For United Research, Inc. — Lakewood, California, United States
• University of Southern California — Los Angeles, California, United States
• USC I.D.S. Pharmacy — Los Angeles, California, United States
• Samaritan Center for Medical Research — Los Gatos, California, United States
• North County Clinical Research — Oceanside, California, United States
• Allied Clinical Research — Roseville, California, United States
• Northern California Research — Sacramento, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Elite Clinical Trials, Inc. — Wildomar, California, United States
• Tennesse Valley Pain Consultants — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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