Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT00131768
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2005-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2005-08-17', 'studyFirstSubmitQcDate': '2005-08-17', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief'}]}, 'conditionsModule': {'keywords': ['osteoarthritis of the ankle', 'musculoskeletal'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic ankle osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the initial 3 months follow up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic OA pain of ankle (talo-crural)\n\nExclusion Criteria:\n\n* Patients with current or prior conditions or treatments that would impede measurements of efficacy or safety'}, 'identificationModule': {'nctId': 'NCT00131768', 'briefTitle': 'A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'orgStudyIdInfo': {'id': 'SYNV-003-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Synvisc (hylan G-F 20)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-60528', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-41462', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Johanna Etienne Krankenhaus', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}, {'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Instituti Ortopedici Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Ospedale Santa Chiara, Clinica Ortopedica, Universita di Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '1100 DD', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Genzyme Corporation'}}}}