Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec

Exclusion Criteria

• •1. History of hypersensitivity to esomeprazole or to another proton-pump inhibitor
• •2. History of allergic reaction or intolerance to any NSAID (including aspirin) and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
• •3. Positive test result for H. pylori at screening
• •4. Participation in any study of an investigational treatment in the 4 weeks before screening
• •5. Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
• •6. Gastrointestinal disorder or surgery leading to impaired drug absorption
• •7. Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would endanger a subject if they were to participate in the study
• •8. Schizophrenia or bipolar disorder
• •9. Use of any excluded concomitant medication (see Section 9.2)
• •10. 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
• •11. Serious blood coagulation disorder, including use of systemic anticoagulants
• •12. Screening endoscopy showing \>10 erosions or any gastric or duodenal ulcer at least 3 mm in diameter with depth
• •13. Screening laboratory ALT or AST value \> 2 times the upper limit of normal
• •14. Estimated creatinine clearance \< 50 ml/min
• •15. Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if they were to participate in the study
• •16. 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