Status:
COMPLETED
GW406381 In Patients With Peripheral Nerve Injury
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hyperalgesia
Neurodynia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00279032
Start Date
September 1 2003
Last Update
February 23 2009
Active Locations (5)
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1
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G12 0YN
2
GSK Investigational Site
Liverpool, Lancashire, United Kingdom, L9 7AL
3
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
4
GSK Investigational Site
Solihull, West Midlands, United Kingdom, B91 2JL