A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
232
Single injection of 3mL Humia inj. Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks
Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks
Huons
Ansan-si, Gyeonggi-do, South Korea
Change from baseline of Weight-bearing pain (100mm-VAS)
Time frame: Week 14
Change from baseline of Weight-bearing pain (100mm-VAS)
Time frame: Weeks 3, 8, 14, and 26
Change from Visit 8 of Weight-bearing pain (100mm-VAS)
Time frame: Week 38
Physical Examination : Swelling
Time frame: Weeks 0, 3, 8, 14, 26, and 38
Physical Examination : Tenderness on pressure
Time frame: Weeks 0,3,8,14,26,and 38
Physical Examination : Range of motion
Time frame: Weeks 0, 3, 8, 14, 26, and 38
Consumption of rescue medication
Time frame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Proportion (%) of patients taking rescue medication
Time frame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Responder Rate
Time frame: Week 14
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