GW406381 In Patients With Peripheral Nerve Injury

Pain Clinical Trial

Official title:

A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Study to Investigate the Effects of Chronic Dose Oral GW406381 on Pain and Areas of Hyperalgesia and Allodynia in Patients With Peripheral Nerve Injury as a Result of Trauma or Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279032
• Other study ID #: CXA10006
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2006
• Last updated: February 19, 2009
• Start date: September 2003

Study information

• Verified date: February 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperalgesia
• Neurodynia
• Pain
• Peripheral Nerve Injuries
• Trauma

Intervention

Drug:
• GW406381

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Leicester	Leicestershire
United Kingdom	GSK Investigational Site	Liverpool	Lancashire
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Solihull	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury
Secondary	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.