This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.
Eligible subjects are randomly assigned to receive DA-5202 high dose(20mg) or DA-5202 low dose(10mg) or Na Hyaluronate once a week intra-articular injection for 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
115
once a week, intra-articular injection, for 3 weeks
once a week, intra-articular injection, for 3 weeks
once a week, intra-articular injection, for 3 weeks
Seoul National University Hospital
Seoul, South Korea
Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3
Time frame: week 3
Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12
Time frame: week 1,2,7,12
Change from baseline of 100mm-VAS about Resting pain in study knee at week 1,2,3,7,12
Time frame: week 1,2,3,7,12
knee joint range of motion change (Observation by investigator)
Time frame: 24 weeks
knee joint effusion change (Observation by investigator)
Time frame: 24 weeks
overall assessment of subject and investigator (5-Likert scale)
Time frame: week 1,2,3,7,12
Change from baseline of 100mm-VAS about Motion pain in study knee at week 1,2,3,7,12
Time frame: week 1,2,3,7,12
Change from baseline of 100mm-VAS about Night pain in study knee at week 1,2,3,7,12
Time frame: week 1,2,3,7,12
Change from baseline of WOMAC Index total score at Week 1,2,3,7,12
Time frame: week 1,2,3,7,12
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