GW406381 In Patients With Peripheral Nerve Injury

Phase 1

Completed

• Conditions: Hyperalgesia; Neurodynia; Pain; Trauma

• Registration Number: NCT00279032
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-19
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-19
• Last Update Posted: 2009-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury

Secondary Outcome Measures

Name	Time	Method
To investigate the effect of 21 days oral dosing of GW406381 on thermal hyperalgesia, dynamic allodynia and static mechanical hyperalgesia in patients with peripheral nerve injury.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom