Phase III Study of CG100649 in Osteoarthritis Patients

Exclusion Criteria

• •1. Use of any analgesics except the study medication or acetaminophen at any time
• •2. Use of any medications for ongoing chronic symptoms, or psychiatric disorders that could significantly diminish the cognitive ability or cause behavioral changes that would prevent the subject from complying with study procedures.
• •3. Subject is legally incompetent, or has active psychosis, or significant emotional problems which are sufficient to interfere with the conduct of the study
• •4. Use of anticoagulants (aspirin, warfarin, heparin, etc.) within 2 weeks of V1
• •5. Previous history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol
• •6. Subjects requiring knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study
• •7. Diagnosed or treated for active GI ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to randomization
• •8. History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock
• •9. Subjects who have had surgery on the affected joint within 6 months prior to the study and subjects with a prosthesis at the index joint
• •10. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
• •11. Subjects who are currently participating or have participated in other clinical studies within 4 weeks of screening or in any other clinical trial evaluating NSAIDs or COX-2 inhibitors within 6 months of screening
• •12. Subjects who have received even one dose of rofecoxib or etoricoxib at any time in their life
• •13. History of congestive heart failure with a status of New York Heart Association II-IV, ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, cerebrovascular disease or subjects who have one of these diseases
• •14. Current user of recreational or illicit drugs or has had a recent history (1 year) of drug or alcohol abuse or dependence
• •15. History of neoplastic disease or chemotherapy within 5 years of V1, with the exception of non-metastatic skin cancer that has been completely cured
• •16. Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
• •17. Subjects using i.v, i.m., or oral corticosteroids, i.a. steroids or hyaluronic acid injections within 1 month of V1
• •18. Subjects receiving a Chinese traditional arthritis treatment within 1 week of V1
• •19. Subjects who are not suitable to participate in the study by the investigator's clinical decision