Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-01 @ 9:13 AM
Study NCT ID:
NCT01860833
Status:
COMPLETED
Last Update Posted:
2013-05-23
First Post:
2013-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NSAID Treatment in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010648', 'term': 'Phenylacetates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-22', 'studyFirstSubmitDate': '2013-05-20', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster universities (WOMAC) osteoarthritis index score', 'timeFrame': '0-14 days', 'description': 'Womac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.'}], 'secondaryOutcomes': [{'measure': 'Naranjo probability scale', 'timeFrame': '14 days', 'description': 'The Naranjo probability scale was used to evaluate the development of adverse drug reaction during this study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '23973155', 'type': 'DERIVED', 'citation': 'Gallelli L, Galasso O, Falcone D, Southworth S, Greco M, Ventura V, Romualdi P, Corigliano A, Terracciano R, Savino R, Gulletta E, Gasparini G, De Sarro G. The effects of nonsteroidal anti-inflammatory drugs on clinical outcomes, synovial fluid cytokine concentration and signal transduction pathways in knee osteoarthritis. A randomized open label trial. Osteoarthritis Cartilage. 2013 Sep;21(9):1400-8. doi: 10.1016/j.joca.2013.06.026.'}]}, 'descriptionModule': {'briefSummary': 'Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.\n\nCertain therapies that specifically interfere with the expression or actions of pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and anti-inflammatory properties and are extensively prescribed for several musculoskeletal disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients. These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA patients with satisfactory relief of painful osteoarthritic joints.\n\nThe aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6, IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular, diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships between proinflammatory cytokines and the clinical status of OA patients are possible, we also evaluated the association between the concentration of these molecules in the osteoarthritic knee synovial fluid and the pain and functional status of patients with OA. The effects of NSAIDS on signal transduction pathways in the synovial membrane were also investigated.', 'detailedDescription': 'not desired'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients eligible for the study were:\n\n* older than 50 years and\n* had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association.\n\nFurther inclusion criteria were:\n\n* clinical signs of joint inflammation (warmth, swelling or effusion) and\n* a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification\n\nExclusion Criteria:\n\n* allergy to NSAIDs,\n* progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease),\n* history of gastrointestinal ulcer or bleeding,\n* a hemoglobin concentration lower than 11.5 g/dL,\n* renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or\n* liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).'}, 'identificationModule': {'nctId': 'NCT01860833', 'acronym': 'NSKO', 'briefTitle': 'NSAID Treatment in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Catanzaro'}, 'officialTitle': 'EFFECTS OF NSAIDs ON CLINICAL OUTCOMES, SYNOVIAL FLUID CYTOKINE CONCENTRATION AND SIGNAL TRANSDUCTION PATHWAYS IN KNEE OSTEOARTHRITIS', 'orgStudyIdInfo': {'id': 'LGOG1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'diclofenac 75 mg/day', 'description': 'diclofenac 75 mg once day slow release', 'interventionNames': ['Drug: Diclofenac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'diclofenac 150 mg/day', 'description': 'diclofenac 75 mg bid', 'interventionNames': ['Drug: Diclofenac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ibuprofen 1200 mg/day', 'description': 'ibuprofen 600 mg bid', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ibuprofen 1800 mg/day', 'description': 'ibuprofen 600 mg tid', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'celecoxib 200 mg/day', 'description': 'celecoxib 200 mg once day', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'celecoxib 400 mg/day', 'description': 'celecoxib 200 mg bid', 'interventionNames': ['Drug: Celecoxib']}], 'interventions': [{'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Brufen'], 'description': 'time of treatment 14 days', 'armGroupLabels': ['ibuprofen 1200 mg/day', 'ibuprofen 1800 mg/day']}, {'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['celebrex'], 'description': 'time of treatment 14 days', 'armGroupLabels': ['celecoxib 200 mg/day', 'celecoxib 400 mg/day']}, {'name': 'Diclofenac', 'type': 'DRUG', 'otherNames': ['voltaren'], 'description': 'time of treatment 14 days', 'armGroupLabels': ['diclofenac 150 mg/day', 'diclofenac 75 mg/day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Department of Orthopedic and Trauma Surgery', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'overallOfficials': [{'name': 'Luca Gallelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Catanzaro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catanzaro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Luca Gallelli', 'investigatorAffiliation': 'University of Catanzaro'}}}}