GW406381 In Patients With Peripheral Nerve Injury
GW406381 In Patients With Peripheral Nerve Injury
The findings from preclinical animal models confirm the peripheral
 anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central
 site of action to the anti-hyperalgesic efficacy that may not be shared by other COX-2
 inhibitors. A central action is consistent with distribution of GW406381 into the CNS in
 animals. Furthermore, preliminary data from a positron emission tomography study in which 6
 healthy male volunteers received a tracer dose of 11C labelled GW406381 indicate that
 GW406381 is rapidly absorbed into the central nervous system in man.
Inclusion criteria:

 -  Baseline average daily Pain Score of greater than or equal to 4 (averaged over the 7
 days prior to Treatment Visit 1), as reported on the 11 point pain intensity numerical
 rating scale.

 -  Subjects on medications for neuropathic pain or received nerve blocks for neuropathic
 pain.

 Exclusion criteria:

 -  Known history of hypersensitivity or intolerance to acetaminophen, paracetamol,
 aspirin, COX-2 inhibitors or NSAIDs.

 -  Subject is unable to discontinue NSAIDs or COX-2 inhibitors (except aspirin as a
 cardioprotective; certain doses apply), topical lidocaine and topical capsaicin for
 the treatment of pain for the period prior to randomization and for the duration of
 the study.

 -  Subject is unable to refrain from sedative use during the study (benzodiazepines
 prescribed as hypnotic sleep agents allowed).

 -  Subject is unable to refrain from nerve blocks for 4 weeks prior to randomisation and
 during the study.