This is a randomized, double-blind, active-controlled, multi-center, phase 3 study to evaluate the safety and efficacy of intraarticular hyaluronic acid(YYD302) for osteoarthritis of the knee after 12 weeks of treatment and retreatment
First Injection: A multicenter, active-controlled, randomized, evaluator and subject bllinded, parallel, phase 3 study Re-Injection: A multicenter, active-controlled, randomized, parallel
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
184
YYD302 2ml
Active comparator: Synovian Inj.
Samsung Medical Center
Seoul, South Korea
Rate of change of the Weight-bearing pain(100mm-VAS) on 12 weeks after first injection in comparison with baseline
Weight-bearing pain(100mm-VAS) assessed by the subject
Time frame: Change of the week 12 from baseline
Rate of change of the Weight-bearing pain(100mm-VAS) on 2, 4 weeks after administration in comparison with baseline
Weight-bearing pain(100mm-VAS) assessed by the subject
Time frame: Change of the week 2, 4 from baseline
Rate of change of the KOOS scales on the 2, 4, 12 weeks after administration in comparison with baseline
KOOS scales assessed by the subject
Time frame: Change of the week 2, 4, 12 from baseline
Rate of change of the rest pain(100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline
Rest pain(100mm-VAS) assessed by the subject
Time frame: Change of the week 2, 4, 12 from baseline
Rate of change of the Motion pain (100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline
Motion pain(100mm-VAS) assessed by the subject
Time frame: Change of the week 2, 4, 12 from baseline
Patient global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline
Patient global assessment (100mm-VAS) assessed by the subject
Time frame: Change of the week 2, 4, 12 from baseline
Investigator global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline
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Patient global assessment (100mm-VAS) assessed by the investigator
Time frame: Change of the week 2, 4, 12 from baseline
Change of the swelling in the knee joint from baseline to 2, 4, 12 weeks after administration
Sweeling assessed by the investigator
Time frame: Change of the week 2, 4, 12 from baseline
Change of the tenderness on pressure in the knee joint from baseline to 2, 4, 12 weeks after administration
Tenderness on pressure assessed by the investigator
Time frame: Change of the week 2, 4, 12 from baseline
Variation of the Range Of Motion(ROM) in the knee joint on 2, 4, 12 weeks after administration with baseline
Range of motion assessed by the investigator
Time frame: Change of the week 2, 4, 12 from baseline
Responder rate of the Weight-bearing pain on 12 weeks in comparison with baseline
Responder rate of the Weight-bearing pain assessed by the investigator
Time frame: Change of the week 12 from baseline
Responder rate of the OMERACT-OARSI on 12 weeks in comparison with baseline
Responder rate of the OMERACT-OARSI assessed by the investigator
Time frame: Change of the week 12 from baseline
Use of rescue medication count and the total amount on each visit after injection
Use of rescue medication count and the total amount assessed by subject
Time frame: Change of the each visit(2, 4, 12, 24, 36 weeks) after injection
The efficacy of secondary outcome 1~11 after 12 weeks(36weeks) compared with the Re-injection(24weeks) in re-injection subjects
Each outcome assessed by the investigator or subject
Time frame: Change of the week 12 (36 weeks) after Re-injection(24weeks)
The efficacy of secondary outcome 1~11 after baseline compared with 2, 4, 12, 24, 36 weeks in Re-injection subjects
Each outcome assessed by the investigator or subject
Time frame: Change of the week 2, 4, 12, 24, 36 from baseline