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

Inclusion Criteria:

• Subjects must have chronic peripheral neuropathic pain present for than 6 months aftera 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 theinteractive voice response system (IVRS), have daily access to a telephone in order tocomplete the IVRS assessments each day, perform telephone visits and complete allrequired assessments/forms.
• Subjects must have sufficient post-traumatic neuropathic pain at screening andbaseline.

Exclusion Criteria:

• Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) orwith Complex Regional Pain Syndrome (CRPS, Type I or Type II).
• Subjects with other pain that may confound assessment or self-evaluation of theperipheral neuropathic pain.
• Subjects who have failed pregabalin treatment due to lack of efficacy with an adequatecourse of therapy at doses greater than or equal to 150 mg/day, who have previouslyparticipated in a pregabalin clinical trial or who have been treated with pregabalinat any time during the 6 month period prior to screening.
• Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIVinfection; 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 3months prior to screening) respiratory, or gastrointestinal disease; symptomaticperipheral vascular disease including intermittent claudication; uncontrolled diabetesmellitus; 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 judgmentand/or details of a risk assessment.
• Use of prohibited medications in the absence of appropriate washout periods.