The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
287
First 2 weeks Placebo(2ml) once weekly in experimental group
Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group
at third week LBSA0103(60mg) once in experimental group
Seoul National University Hospital
Jongno-gu, Seoul, South Korea
Weight-bearing pain
using 100mm-VAS
Time frame: 12 weeks after the last injection
Weight-bearing pain
using 100mm-VAS
Time frame: 1,6 weeks after the last injection
WOMAC-likert assessment
Pain, Function, Stiffness, Total score
Time frame: 1,6,12 weeks after the last injection
Patient Global Assessment
using 100mm-VAS
Time frame: 1,6,12 weeks after the last injection
Investigator Global Assessment
using 100mm-VAS
Time frame: 1,6,12 weeks after the last injection
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