Study in Neuropathic Pain Patients With Peripheral Nerve Injury
Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
Summary
This study will be a double-blind, placebo-controlled, parallel group study. After enrolment
and initial assessments, subjects will receive oral GW856553 7.5 milligram (mg) twice daily
(BID) or matching placebo for 28 days in a 1:1 ratio. Sufficient numbers of subjects will be
recruited to obtain 142 evaluable subjects. This is a double-blind, randomized,
placebo-controlled, parallel group study. Subjects will undertake a screening period which
may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomized
treatment period of 4 weeks and a follow-up period of approximately 2 weeks. This is a
multi-centre, double-blind, randomized, placebo-controlled study in subjects who have at
least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to
trauma or surgery. It will investigate the efficacy, safety and tolerability of GW856553 over
28 days of treatment. Approximately 158 subjects will be randomized to ensure 142 evaluable
subjects. Randomization ratio will be 1:1 for placebo or GW856553 respectively. The dose of
GW856553 will be 7.5 mg BID.