protocolSection identificationModule nctId: NCT06307847, orgStudyIdInfo id: SP-HA-003, briefTitle: Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-14, primaryCompletionDateStruct date: 2022-10-25, completionDateStruct date: 2022-10-25, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Shin Poong Pharmaceutical Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind, multicenter, non-inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M001) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis., conditionsModule conditions: Osteoarthritis Thumb, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 223, type: ACTUAL, armsInterventionsModule interventions name: SP5M001 inj, interventions name: Synovian inj, outcomesModule primaryOutcomes measure: Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2), secondaryOutcomes measure: Changes in the following at each visit : Weight Bearing pain(WBP) (Weeks 2, 6, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Investigator Global Assessment (IGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Changes in the following at each visit : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total score and individual score evaluation (Pain, function, stiffness) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2), secondaryOutcomes measure: Physical assessments at each post-administration visit: Swelling (Weeks 2, 6, 12, 24, and 36), secondaryOutcomes measure: Physical assessments at each post-administration visit: joint-line tenderness on pressure (Weeks 2, 6, 12, 24, and 36), secondaryOutcomes measure: Physical assessments at each post-administration visit: range of motion (Weeks 2, 6, 12, 24, and 36), secondaryOutcomes measure: Proportion of participants who took rescue medication at each post-administration visit and dose of rescue medication (Weeks 2, 6, 12, 24, and 36), secondaryOutcomes measure: Post-administration response rate A. Proportion at which WBP decreases by at least 20 mm or improves by at least 40% from baseline at the time of evaluation (B section-Description), otherOutcomes measure: The incidence rate of Pre-treatment AEs, otherOutcomes measure: The incidence rate of Solicited Local AEs, otherOutcomes measure: The incidence rate of treatment-emergent adverse event (TEAE), otherOutcomes measure: The incidence rate of Serious TEAEs, otherOutcomes measure: The incidence rate of Serious TEAEs leading to Drug withdrawn, otherOutcomes measure: The incidence rate of Serious TEAEs leading to Death, otherOutcomes measure: The incidence rate of abnormal CS at Post-Treatment on Laboratory, otherOutcomes measure: The incidence rate of abnormal CS at Post-Treatment on Electrocardiogram, otherOutcomes measure: The incidence rate of abnormal on Physical Examination, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yeungnam University Medical Center, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Cheonam National University Hwasun Hospital, city: Hwasun, country: Korea, Republic of, geoPoint lat: 35.06125, lon: 126.98746, locations facility: Gachon University Gil Medical Center, city: Incheon, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Jeonbuk National University Hospital, city: Jeonju, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, locations facility: Chungnam National University Hospital, city: Sejong, country: Korea, Republic of, geoPoint lat: 36.59245, lon: 127.29223, locations facility: Seoul National University Bundang Hospital, city: Seongnam-si, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Asan Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Chung-ang University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kyung Hee University Hospital at Gangdong, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kyunghee University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Samsung Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Seoul National University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Soon Chun Hyang University Hospital Seoul, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: The Catholic University of Korea, Seoul St. Mary's Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False