Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT00279032
Status:
COMPLETED
Last Update Posted:
2009-02-23
First Post:
2006-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GW406381 In Patients With Peripheral Nerve Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006930', 'term': 'Hyperalgesia'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C469818', 'term': 'GW406381X'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'lastUpdateSubmitDate': '2009-02-19', 'studyFirstSubmitDate': '2006-01-17', 'studyFirstSubmitQcDate': '2006-01-17', 'lastUpdatePostDateStruct': {'date': '2009-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury'}], 'secondaryOutcomes': [{'measure': '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.'}]}, 'conditionsModule': {'keywords': ['GW406381', 'peripheral nerve injury', 'patients', 'allodynia', 'hyperalgesia', 'randomised', 'placebo-controlled'], 'conditions': ['Hyperalgesia', 'Neurodynia', 'Pain', 'Trauma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 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.\n* Subjects on medications for neuropathic pain or received nerve blocks for neuropathic pain.\n\nExclusion criteria:\n\n* Known history of hypersensitivity or intolerance to acetaminophen, paracetamol, aspirin, COX-2 inhibitors or NSAIDs.\n* 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.\n* Subject is unable to refrain from sedative use during the study (benzodiazepines prescribed as hypnotic sleep agents allowed).\n* Subject is unable to refrain from nerve blocks for 4 weeks prior to randomisation and during the study.'}, 'identificationModule': {'nctId': 'NCT00279032', 'briefTitle': 'GW406381 In Patients With Peripheral Nerve Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'CXA10006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GW406381', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'B91 2JL', 'city': 'Solihull', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.41426, 'lon': -1.78094}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}}