GW406381 In Patients With Peripheral Nerve Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279032
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : February 23, 2009
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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.

Condition or disease Intervention/treatment Phase
Hyperalgesia Neurodynia Pain Trauma Drug: GW406381 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : September 2003

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Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279032

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
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00279032     History of Changes
Other Study ID Numbers: CXA10006
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: February 23, 2009
Last Verified: February 2009

Keywords provided by GlaxoSmithKline:
peripheral nerve injury

Additional relevant MeSH terms:
Peripheral Nerve Injuries
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Trauma, Nervous System
Wounds and Injuries