Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee

• Drug: Meloxicam
  7.5mg x2 once a day for 12 weeks
  Other Name: Mobic
• Drug: Placebo
  Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.

• Meloxicam
  Intervention: Drug: Meloxicam
• Placebo Comparator: Placebo
  2 Placebo capsules once a day for 12 weeks
  Intervention: Drug: Placebo

Inclusion Criteria:

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

Exclusion Criteria:

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