NCT01110057

Efficacy Study in Lumbosacral Radiculopathy

A Randomised, Double Blind Study to Evaluate the Safety and Efficacy of the p38 Kinase Inhibitor, GW856553, in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will be a double-blind, placebo-controlled, parallel group study. After enrolment and initial assessments, subjects will receive 35 days of study medication. During this treatment period, they will be randomised to either oral GW856553 7.5mg BID or matching placebo in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 128 evaluable subjects.

Detailed description

This is a double-blind, randomised, 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 randomised treatment period of 5 weeks and a follow-up period of approximately 2 weeks. This is a multi-centre, double-blind, randomised, placebo-controlled study in subjects who have at least moderate intensity of neuropathic pain resulting from lumbosacral radiculipathy. It will investigate the efficacy, safety and tolerability of GW856553. Approximately 142 subjects will be randomised to ensure 128 evaluable subjects. Randomisation ratio will be 1:1 for placebo or GW856553 respectively. The dose of GW856553 will be 7.5 mg BID.

Conditions

• Pain, Neuropathic

Interventions

Type	Name	Description
DRUG	Placebo	Placebo to match GW856553
DRUG	GS856553	GW586553 7.5mg bid

Timeline

• Start date: 2010-01-07
• Primary completion: 2010-08-23
• Completion: 2010-08-23
• First posted: 2010-04-23
• Last updated: 2017-06-08

Locations

17 sites across 5 countries: Denmark, France, Germany, Norway, Sweden