Back to resultsGW406381 In Patients With Peripheral Nerve Injury
Primary Purpose
Hyperalgesia, Neurodynia, Pain
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GW406381
Sponsored by
About this trial
This is an interventional treatment trial for Hyperalgesia focused on measuring GW406381, peripheral nerve injury, patients, allodynia, hyperalgesia, randomised, placebo-controlled
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00279032
Brief Title
GW406381 In Patients With Peripheral Nerve Injury
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia, Neurodynia, Pain, Trauma
Keywords
GW406381, peripheral nerve injury, patients, allodynia, hyperalgesia, randomised, placebo-controlled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW406381
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Liverpool
State/Province
Lancashire
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Solihull
State/Province
West Midlands
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
GW406381 In Patients With Peripheral Nerve Injury
We'll reach out to this number within 24 hrs