GW406381 In Patients With Peripheral Nerve Injury

GlaxoSmithKline40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hyperalgesia Neurodynia Pain Trauma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (5)

GSK Investigational Site

Glasgow, Lanarkshire, United Kingdom

GSK Investigational Site

Liverpool, Lancashire, United Kingdom

GSK Investigational Site

Leicester, Leicestershire, United Kingdom

GSK Investigational Site

Solihull, West Midlands, United Kingdom

GSK Investigational Site

London, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.