Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis

Exclusion Criteria

• •1. Subjects with rheumatoid arthritis or gout/pseudo-gout
• •2. Subjects with fibromyalgia syndrome
• •3. Acute joint trauma at the index joint within the 3 months prior to screen with active symptoms
• •4. Previous (in the past 12 months) or anticipated need for surgical or invasive procedure performed on the index joint during the study
• •5. Subject was currently taking or anticipated to take Coumadin®, warfarin, or lithium
• •6. History of hypersensitivity to esomeprazole or to another PPI
• •7. History of allergic reaction or intolerance to any NSAID (including aspirin) and/or subject had a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
• •8. History of allergic reactions to sulfonamides
• •9. Subjects with intra-articular or intramuscular corticosteroids or intra-articular hyaluronic acid injections within 8 weeks prior to randomization
• •10. Participation in any study of an investigational treatment in the 4 weeks before Screening
• •11. Presence of uncontrolled acute or chronic medical illness, e.g. morbid obesity, GI disorder, diabetes, active GI disease, chronic or acute renal or hepatic disorder, depression and/or infection, etc, that would endanger a subject if the subject were to participate in the study
• •12. GI disorder (e.g., severe erosive esophagitis, Zollinger Ellison syndrome) or surgery leading to impaired drug absorption
• •13. Peptic ulcer disease within 6 months prior to Screening
• •14. Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would have endangered a subject if the subject were to participate in the study
• •15. Schizophrenia or bipolar disorder
• •16. Subjects who had started physical therapy on the index joint less than 6 weeks prior to study Screening
• •17. Use of any excluded concomitant medication
• •18. A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain
• •19. Serious blood coagulation disorder including use of systemic anti-coagulants
• •20. Screening laboratory value for alanine aminotransferase, aspartate aminotransferase greater than 2 times the upper limit of normal
• •21. Estimated creatinine clearance less than 30 ml/min
• •22. Other than noted specifically, any Screening laboratory value that was clinically significant in the investigator's opinion and would have endangered a subject if the subjects were to participate in the study
• •23. History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
• •24. Previous participation in another PN 400 clinical research trial
• •25. Subjects who were employees of the research facility or who were in some way under the supervision of the principal investigator for this study