The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
456
Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg
Drug: Celecoxib 200mg
Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo
KyungHee University Medical Center
Seoul, South Korea
Change From Baseline in VAS score to assess pain at Week 12
Time frame: baseline and week 12
Change From Baseline in VAS score to assess pain at Week 4, 8
Time frame: baseline, week 4 and week 8
Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12
Time frame: baseline, week 4, week 8 and week 12
Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12
Time frame: baseline, week 4, week 8 and week 12
Percentage From Baseline in WOMAC responder at Week 4, 8, 12
Time frame: baseline, week 4, week 8 and week 12
Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12
Time frame: week 12
Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12
Time frame: week 12
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