- Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral
neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain
(including post-surgical), confirmed by a qualified pain specialist.
- Subjects must have completed at least 4 daily pain diaries during the 7 days prior to
Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2
(randomization).
- Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain
(including post-surgical), that may confuse or confound the assessment of neuropathic
pain.
- Presence of any severe pain associated with conditions other than DPN, PHN, or
post-traumatic neuropathic pain (including post-surgical) that may confound the
assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic
neuropathic pain (including post-surgical).
- Creatinine clearance
and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for
subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day