Last updated: 11/04/2018 06:06:14
GW406381 In Patients With Peripheral Nerve Injury
GSK study ID
CXA10006
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW406381
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hyperalgesia, Neurodynia, Trauma
Product
GW406381
Collaborators
Not applicable
Study date(s)
September 2003 to December 2005
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
no
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Status
Will Be Recruiting
Location
GSK Investigational Site
Liverpool, Lancashire, United Kingdom, L9 7AL
Status
Will Be Recruiting
Location
GSK Investigational Site
Solihull, West Midlands, United Kingdom, B91 2JL
Status
Will Be Recruiting
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-13-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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