Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2026-01-21 @ 1:37 AM
Study NCT ID:
NCT04369261
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2020-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1949}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-28', 'studyFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety endpoints', 'timeFrame': 'Week 2', 'description': 'injection site reactions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis in the Knee']}, 'referencesModule': {'references': [{'pmid': '34192989', 'type': 'DERIVED', 'citation': 'Jang KM, Park YG, Choi WK, Chung YY, Kim KK, Lee JW, Lee SJ, Eom Y, Yang JH. Safety of a single intra-articular injection of LBSA0103 hyaluronic acid in patients with osteoarthritis of the knee: a multicenter, single-arm, prospective, cohort study. Curr Med Res Opin. 2021 Sep;37(9):1573-1580. doi: 10.1080/03007995.2021.1950132. Epub 2021 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A patient from hospital and clinic as well', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female patient of over 19 years of age\n* A patient diagnosed with knee osteoarthritis\n* A patient who has been informed of the purpose, method of the study and signed the written informed consent form.\n\nExclusion Criteria:\n\n* A patient who shows hypersensitive reaction to the Synovian® Inj. or to the ingredients of Synovian® Inj.\n* A patient with infection at the joint\n* A patient with skin infection or skin disease at the injection area\n* A patient diagnosed with osteoarthritis with the Kellgren \\& Lawrence Grade IV in X-ray within 12 months before enrollment of this study.'}, 'identificationModule': {'nctId': 'NCT04369261', 'briefTitle': 'Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Multicenter, Prospective Observational Study to Evaluate the Injection Site Reactions of Synovian® Inj. in Patients With Osteoarthritis in the Knee', 'orgStudyIdInfo': {'id': 'LG-HAOS006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Synovian®', 'type': 'DRUG', 'description': 'Synovian® Inj.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11923', 'city': 'Guri-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hanyang University GURI Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'not decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}