GW406381 In Patients With Peripheral Nerve Injury

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Neurodynia

Hyperalgesia

Trauma

Pain

Treatments

Drug: GW406381

Study type

Interventional

Funder types

Industry

Identifiers

NCT00279032

CXA10006

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.