A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis
Phase 2
Completed
- Conditions
- Knee Osteoarthritis
- Interventions
- Registration Number
- NCT02759198
- Lead Sponsor
- Yuhan Corporation
- Brief Summary
The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 456
Inclusion Criteria
- Signed Informed Consent
- Men and women ≥ 40 years of age
- Patients with knee osteoarthritis at one or both knee by ACR
Exclusion Criteria
- Patients with known or suspected secondary knee osteoarthritis
- Other exclusions applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YH23537 YH23537 YH23537 750/1500/3000mg Placebo YH23537 placebo YH23537 Placebo Celebrex Celecoxib Celecoxib 200mg
- Primary Outcome Measures
Name Time Method Change From Baseline in VAS score to assess pain at Week 12 baseline and week 12
- Secondary Outcome Measures
Name Time Method Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12 baseline, week 4, week 8 and week 12 Percentage From Baseline in WOMAC responder at Week 4, 8, 12 baseline, week 4, week 8 and week 12 Change From Baseline in VAS score to assess pain at Week 4, 8 baseline, week 4 and week 8 Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12 week 12 Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12 baseline, week 4, week 8 and week 12 Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12 week 12
Trial Locations
- Locations (1)
KyungHee University Medical Center
🇰🇷Seoul, Korea, Republic of