Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-28 @ 2:01 AM
Study NCT ID:
NCT01510535
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2012-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2012-01-06', 'studyFirstSubmitQcDate': '2012-01-11', 'lastUpdatePostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight-bearing pain', 'timeFrame': '12 weeks after the last injection', 'description': 'using 100mm-VAS'}], 'secondaryOutcomes': [{'measure': 'Weight-bearing pain', 'timeFrame': '1,6 weeks after the last injection', 'description': 'using 100mm-VAS'}, {'measure': 'WOMAC-likert assessment', 'timeFrame': '1,6,12 weeks after the last injection', 'description': 'Pain, Function, Stiffness, Total score'}, {'measure': 'Patient Global Assessment', 'timeFrame': '1,6,12 weeks after the last injection', 'description': 'using 100mm-VAS'}, {'measure': 'Investigator Global Assessment', 'timeFrame': '1,6,12 weeks after the last injection', 'description': 'using 100mm-VAS'}]}, 'conditionsModule': {'keywords': ['Osteoartritis', 'Knee', 'LBSA0103', 'Hyruan Plus Inj.'], 'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'pmid': '28549436', 'type': 'DERIVED', 'citation': 'Ha CW, Park YB, Choi CH, Kyung HS, Lee JH, Yoo JD, Yoo JH, Choi CH, Kim CW, Kim HC, Oh KJ, Bin SI, Lee MC. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord. 2017 May 26;18(1):223. doi: 10.1186/s12891-017-1591-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over 40 years of age\n* Kellgren \\& Lawrence grade I-III\n* If there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS\n* Be willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study\n\nExclusion Criteria:\n\n* Body mass index \\> 32\n* Have rheumarthritis\n* Patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS\n* Have Sudek's atrophy, Paget's disease, Spinal disc herniation\n* Kellgren \\& Lawrence Grade IV"}, 'identificationModule': {'nctId': 'NCT01510535', 'briefTitle': 'Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'An Double-blind, Active-controlled, Parallel-group, Randomized, Multi-center Study to Compare Efficacy and Safety of LBSA0103 Once Versus Hyruan Plus Injection Once Weekly for 3weeks in the Treatment of Patients With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'LG-HACL010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo and then LBSA0103', 'description': 'The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee.', 'interventionNames': ['Drug: Placebo', 'Drug: LBSA0103']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyruan Plus', 'description': 'The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee.', 'interventionNames': ['Drug: Hyruan Plus']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'First 2 weeks Placebo(2ml) once weekly in experimental group', 'armGroupLabels': ['Placebo and then LBSA0103']}, {'name': 'Hyruan Plus', 'type': 'DRUG', 'description': 'Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group', 'armGroupLabels': ['Hyruan Plus']}, {'name': 'LBSA0103', 'type': 'DRUG', 'description': 'at third week LBSA0103(60mg) once in experimental group', 'armGroupLabels': ['Placebo and then LBSA0103']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jongno-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}