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GW406381 In Patients With Peripheral Nerve Injury

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00279032
First received: January 17, 2006
Last updated: February 19, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperalgesia
Neurodynia
Pain
Trauma
 Drug: GW406381
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 40
Study Start Date: September 2003
Intervention Details:
    Drug: GW406381
    Other Name: GW406381
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279032

Locations
United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G12 0YN
GSK Investigational Site
Liverpool, Lancashire, United Kingdom, L9 7AL
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
GSK Investigational Site
Solihull, West Midlands, United Kingdom, B91 2JL
GSK Investigational Site
London, United Kingdom, W12 0NN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00279032     History of Changes
Other Study ID Numbers: CXA10006
Study First Received: January 17, 2006
Last Updated: February 19, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
GW406381
peripheral nerve injury
patients
allodynia
 hyperalgesia
randomised
placebo-controlled

Additional relevant MeSH terms:
Hyperalgesia
Neuralgia
Wounds and Injuries
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on May 19, 2013