Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 8:49 PM
Study NCT ID:
NCT00927004
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
2009-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D006930', 'term': 'Hyperalgesia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077613', 'term': 'Etoricoxib'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-01', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-23', 'lastUpdatePostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Pain Threshold', 'timeFrame': '15 days, 3 days'}, {'measure': 'Western Ontario and McMaster University Osteoarthritis Index (knee) - pain subscale', 'timeFrame': '15 days, 3 days'}], 'secondaryOutcomes': [{'measure': 'Cold Pain Threshold', 'timeFrame': '15 days, 3 days'}, {'measure': 'Topical Cold Response', 'timeFrame': '15 days, 3 days'}, {'measure': 'Functional Measure (aggregated locomotor score, sit-to-stand time)', 'timeFrame': '15 days, 3 days'}, {'measure': 'WOMAC (knee) total', 'timeFrame': '15 days, 3 days'}, {'measure': 'SF-36v2', 'timeFrame': '15 days, 3 days'}, {'measure': 'Pain Quality Assessment Scale', 'timeFrame': '15 days, 3 days'}, {'measure': 'PainDETECT questionnaire', 'timeFrame': '15 days, 3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mechanical hyperalgesia', 'cold hyperalgesia', 'chronic pain'], 'conditions': ['Osteoarthritis', 'Pain']}, 'referencesModule': {'references': [{'pmid': '28778815', 'type': 'DERIVED', 'citation': 'Moss P, Benson HAE, Will R, Wright A. Fourteen days of etoricoxib 60 mg improves pain, hyperalgesia and physical function in individuals with knee osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2017 Nov;25(11):1781-1791. doi: 10.1016/j.joca.2017.07.009. Epub 2017 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to better understand the way in which painful osteoarthritis affects different people and whether an anti-inflammatory medication such as Arcoxia (etoricoxib) can help to modify this pain. The study will use questionnaires and tests of pain sensitivity to identify arthritis sufferers with more widespread, nerve-type pain and then to investigate whether a daily dose of Arcoxia is more effective than a placebo pill in reducing these symptoms and improving functional movements. The study will also be comparing the same test results of a small group of subjects without knee pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral diagnosis of Knee OA \\> 6 months\n* knee pain \\> 4/10 on WOMAC pain subscale\n* if pain in contralateral knee, no greater than "mild"\n* no other significant joint involvement\n* ARA functional Class I, II or III\n* no arthroscopy or injections into index knee in last 6 months\n\nExclusion Criteria:\n\n* history of systemic inflammatory or chronic pain disorders (especially fibromyalgia)\n* neurological deficit\n* recent (\\< 6 months) lower limb surgery\n* allergic reaction to NSAIDs or aspirin\n* skin allergies, dermatitis\n* contraindications to Cox-2 inhibitors:\n\n * congestive heart failure (NYHA II-IV)\n * unstable hypertension\n * ischaemic heart disease\n * peripheral artery disease\n * cerebrovascular disease including CABG or angioplasty within 1 year\n* severe hepatic dysfunction\n* active GI bleeding or peptic ulceration\n* reduced creatinine clearance \\< 30 mL/min\n* current use of high dose (\\> 325 mg daily) aspirin'}, 'identificationModule': {'nctId': 'NCT00927004', 'briefTitle': 'Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Curtin University'}, 'officialTitle': 'A Randomised Placebo-controlled Trail of Mechanical and Cold Hyperalgesia in Subjects With Painful Knee Osteoarthritis, Compared With Matched Controls, & Whether This Hyperalgesia Can be Modified by a 2-week Course of Etoricoxib 60mg.', 'orgStudyIdInfo': {'id': 'Moss IISP#36409'}, 'secondaryIdInfos': [{'id': '3144 Wright-Merck'}, {'id': 'HR47-2009'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etoricoxib 60 mg', 'interventionNames': ['Drug: Etoricoxib (Arcoxia)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'interventionNames': ['Drug: Sugar pill']}], 'interventions': [{'name': 'Etoricoxib (Arcoxia)', 'type': 'DRUG', 'otherNames': ['Arcoxia'], 'description': '60 mg, daily dose, oral delivery, 14 days duration', 'armGroupLabels': ['Etoricoxib 60 mg']}, {'name': 'Sugar pill', 'type': 'DRUG', 'description': 'Daily dose (1 pill), oral delivery, 14 days', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Tony Wright, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Curtin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Curtin University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Penny Moss', 'investigatorAffiliation': 'Curtin University'}}}}