- 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.
- 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.