Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: pregabalin; placebo
Intervention description: capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization; capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 542.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post-traumatic peripheral neuropathic pain

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.
    

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.