A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

A Multicenter，Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis

The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.

Inclusion Criteria:

• Aged form 18 years to 75 years old
• Diagnosed with osteoarthritis of the knee according to the American College of Rheumatology
• Functional capacity class of Ⅰ-Ⅲ

Exclusion Criteria:

• Unstable angina
• History of myocardial infarction within the last 6 months
• Stroke in the 6 months before screening
• New York Heart Association class Ⅲ-Ⅳ congestive heart-failure
• Systolic blood pressure>180mmHg,and/or Diastolic blood pressure>100mmHg
• Peptic ulcer
• Known contraindications to non-steroidal anti-inflammatory drug（NSAID）
• Received aspirin within 3 days of baseline visit
• Aspirin dosage>150mg/d
• Known to be Allergic to sulfa and COX-2 inhibitors
• Pregnancy or lactation
• Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>2 times upper limit of normal
• Blood urine nitrogen>1.5 times upper limit of normal