Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT04732793
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore', 'timeFrame': 'from Baseline to 13 weeks post injection.', 'description': 'The WOMAC Likert Index measures 3 separate dimensions: pain, stiffness, and function. The subject will self assess the level of pain in the target knee joint for the prior 48 hours (5 questions), the level of difficulty of performing daily activities (17 questions), and the level of stiffness (2 questions) using the WOMAC Likert Questionnaire (24 total questions; 4 points/question).\n\nEach item of the WOMAC Likert Index will be assessed using the scale of 0=none, 1=a little, 2=moderate, 3=severe, 4=very severe. The aggregate total score that can result for each scale is as follows:\n\nPain = 0-20 Stiffness = 0-8 Physical function = 0-68.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis (OA) of the Knee']}, 'descriptionModule': {'briefSummary': 'To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is ≥40 years old.\n2. Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale grade II III) in one or both knees. Radiographs to be taken within 12 months prior to the Screening visit.\n3. Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.\n\nExclusion Criteria:\n\n1. Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.\n2. Subject has a documented history of hypersensitivity to HA.\n3. Subject has a documented infection or severe inflammation of the target knee joint.\n4. Subject has a skin disease in the area of the injection site.\n5. Subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).\n6. Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.'}, 'identificationModule': {'nctId': 'NCT04732793', 'briefTitle': 'To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Prospective, Active Controlled, Randomised, Parallel Group, Double Blind, Multicentre Study to Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe', 'orgStudyIdInfo': {'id': 'LG-HACL026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyruan ONE®', 'interventionNames': ['Device: Hyruan ONE®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Durolane®', 'interventionNames': ['Device: Durolane®']}], 'interventions': [{'name': 'Hyruan ONE®', 'type': 'DEVICE', 'description': 'For use as a symptomatic treatment of osteoarthritis (OA) of the knee', 'armGroupLabels': ['Hyruan ONE®']}, {'name': 'Durolane®', 'type': 'DEVICE', 'description': 'For use as a symptomatic treatment of osteoarthritis (OA) of the knee', 'armGroupLabels': ['Durolane®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21-040', 'city': 'Świdnik', 'country': 'Poland', 'facility': 'Lubelskie Centrum Diagnostyczne', 'geoPoint': {'lat': 51.21898, 'lon': 22.69621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}