nctId: NCT06307847 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 overallStatus: COMPLETED date: 2021-04-14 date: 2022-10-25 date: 2022-10-25 date: 2024-03-13 date: 2024-03-13 name: Shin Poong Pharmaceutical Co. Ltd. class: INDUSTRY 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. conditions: Osteoarthritis Thumb studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 223 type: ACTUAL name: SP5M001 inj name: Synovian inj measure: Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2) measure: Changes in the following at each visit : Weight Bearing pain(WBP) (Weeks 2, 6, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Investigator Global Assessment (IGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) 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) measure: Physical assessments at each post-administration visit: Swelling (Weeks 2, 6, 12, 24, and 36) measure: Physical assessments at each post-administration visit: joint-line tenderness on pressure (Weeks 2, 6, 12, 24, and 36) measure: Physical assessments at each post-administration visit: range of motion (Weeks 2, 6, 12, 24, and 36) 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) 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) measure: The incidence rate of Pre-treatment AEs measure: The incidence rate of Solicited Local AEs measure: The incidence rate of treatment-emergent adverse event (TEAE) measure: The incidence rate of Serious TEAEs measure: The incidence rate of Serious TEAEs leading to Drug withdrawn measure: The incidence rate of Serious TEAEs leading to Death measure: The incidence rate of abnormal CS at Post-Treatment on Laboratory measure: The incidence rate of abnormal CS at Post-Treatment on Electrocardiogram measure: The incidence rate of abnormal on Physical Examination sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yeungnam University Medical Center city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Cheonam National University Hwasun Hospital city: Hwasun country: Korea, Republic of lat: 35.06125 lon: 126.98746 facility: Gachon University Gil Medical Center city: Incheon country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Jeonbuk National University Hospital city: Jeonju country: Korea, Republic of lat: 35.82194 lon: 127.14889 facility: Chungnam National University Hospital city: Sejong country: Korea, Republic of lat: 36.59245 lon: 127.29223 facility: Seoul National University Bundang Hospital city: Seongnam-si country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Asan Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Chung-ang University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kyung Hee University Hospital at Gangdong city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kyunghee University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Samsung Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Seoul National University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Soon Chun Hyang University Hospital Seoul city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: The Catholic University of Korea, Seoul St. Mary's Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False