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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00279032 |
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 |
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Hyperalgesia Neurodynia Pain Trauma |
Drug: GW406381 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 40 |
Study Start Date: | September 2003 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United Kingdom | |
GSK Investigational Site | |
London, United Kingdom, W12 0NN | |
United Kingdom, Lanarkshire | |
GSK Investigational Site | |
Glasgow, Lanarkshire, United Kingdom, G12 0YN | |
United Kingdom, Lancashire | |
GSK Investigational Site | |
Liverpool, Lancashire, United Kingdom, L9 7AL | |
United Kingdom, Leicestershire | |
GSK Investigational Site | |
Leicester, Leicestershire, United Kingdom, LE1 5WW | |
United Kingdom, West Midlands | |
GSK Investigational Site | |
Solihull, West Midlands, United Kingdom, B91 2JL |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CXA10006 |
Study First Received: | January 17, 2006 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00279032 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
GW406381 peripheral nerve injury patients allodynia |
hyperalgesia randomised placebo-controlled |
Signs and Symptoms Sensation Disorders Somatosensory Disorders Neuromuscular Diseases Neuralgia |
Peripheral Nervous System Diseases Wounds and Injuries Neurologic Manifestations Pain Hyperalgesia |
Signs and Symptoms Sensation Disorders Somatosensory Disorders Neuromuscular Diseases Neuralgia |
Peripheral Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain Hyperalgesia |