Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 7:02 AM
Study NCT ID:
NCT00440661
Status:
COMPLETED
Last Update Posted:
2010-03-04
First Post:
2007-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025292', 'term': 'diacerein'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-03', 'studyFirstSubmitDate': '2007-02-26', 'studyFirstSubmitQcDate': '2007-02-26', 'lastUpdatePostDateStruct': {'date': '2010-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Synovial concentration of IL-1'}], 'secondaryOutcomes': [{'measure': 'Synovial concentration of IL-6'}, {'measure': 'WOMAC'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis, IL-1'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation mediators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Painful osteoarthritis\n* Hydarthrosis (synovial effusion)\n\nExclusion Criteria:\n\n* large effusion\n* severe pathologies\n* anti-osteoarthritic treatments'}, 'identificationModule': {'nctId': 'NCT00440661', 'briefTitle': 'Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires NEGMA'}, 'officialTitle': 'Exploratory Study of Some Synovial Fluid Inflammation Mediatorsunder Diacerhein in Knee Osteoarthritis Patients. Phase IV Study.', 'orgStudyIdInfo': {'id': 'HEC/ART06572N'}, 'secondaryIdInfos': [{'id': '109196'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Diacerhein', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2L1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Rheumatologic Institut of Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jean-Pierre RAYNAULD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Rhumatologie de Montreal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires NEGMA', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Patrick Darses', 'oldOrganization': 'Negma-Lerads'}}}}