Study in Neuropathic Pain Patients With Peripheral Nerve Injury

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.

Timeline

Start

2009-08

Primary completion

2010-07

Completion

2010-07

Publications

• Background Thor Ostenfeld, Nathalie E. Richard, Alok Krishen, Robert Y. Lai, Jonathan Bullman, Amanda J. Baines, Joanne Green, Praveen Anand, Madeline Kelly . A randomised, double blind, placebo controlled study to evaluate the analgesic efficacy and safety of the novel p38 MAP kinase inhibitor, losmapimod, in patients with neuropathic pain following peripheral nerve injury . Eur J Pain. 2012;(Dec 14):

Drugs

Indications