Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-29 @ 8:53 PM
Study NCT ID:
NCT00139295
Status:
COMPLETED
Last Update Posted:
2014-02-05
First Post:
2005-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-04', 'studyFirstSubmitDate': '2005-08-29', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain relief'}]}, 'conditionsModule': {'keywords': ['musculoskeletal', 'osteoarthritis of the knee'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with OA of the knee\n* Have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications\n\nExclusion Criteria:\n\n* Prior or concomitant treatments that would impede measurement of safety and efficacy'}, 'identificationModule': {'nctId': 'NCT00139295', 'briefTitle': 'Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'AVS00103'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hylastan', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Capstone Clinical Trials, Inc', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Orthopedic Institute, PC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopaedic Specialties of Tampa Bay', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Center for Clinical Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Orthopedics at Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61103', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Health Physicians', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Orthopedic Specialists of Louisiana', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Arthritis & Osteoporosis Center of Maryland', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '01610', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Pharmacology Study Group', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '97527', 'city': 'Grants Pass', 'state': 'Oregon', 'country': 'United States', 'facility': 'Orthopedic Center for Joint Replacement and Sports', 'geoPoint': {'lat': 42.43933, 'lon': -123.33067}}, {'zip': '29526', 'city': 'Conway', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Orthopedic Associates', 'geoPoint': {'lat': 33.836, 'lon': -79.04781}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Unlimited Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98166', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Arthritis Northwest', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'L9C 7N4', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sir William Osler Health Institute', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': '33700', 'city': 'Mérignac', 'country': 'France', 'facility': 'Clinique du Sport', 'geoPoint': {'lat': 44.84247, 'lon': -0.64512}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon-Sud, Service de Rhumatologie', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Hôpital Trousseau Service de Rhumatologie', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '69121', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '28844', 'city': 'Weyhe-Kirchweyhe', 'country': 'Germany', 'facility': 'Orthopaedische Gemeinschaftspraxis'}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital, MRC Environmental Epidemiology Unit', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Maidstone General Hospital & Tunbridge Wells NHS Trust', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'E11 1NR', 'city': 'Leytonstone', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department', 'geoPoint': {'lat': 51.56856, 'lon': 0.00768}}], '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'}}}}