Subjects are required to meet the following criteria to be eligible for Randomization into
this study:
- Male or female Chinese subjects, 18-75 years of age;
- Subjects must have a diagnosis of OA of the index knee based on American College of
Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of
greater than or equal to 2) (Kellgren J. & Lawrence J, 1957)
- Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and
at Baseline based on four daily diary entries
Subjects presenting with any of the following will not be included in the study:
- History of other disease that may involve the index (painful) knee including
inflammatory joint diseases or have had recent surgical intervention on the knee.
- Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or
duodenal ulceration within 30 days prior to receiving the first dose of study
medication. History of or active gastrointestinal disease (eg, inflammatory bowel
disease), a chronic or acute renal or hepatic disorder, or a significant coagulation
defect.
- Signs and symptoms of clinically significant cardiac disease