A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)

Exclusion Criteria

• •1. History of hypersensitivity to esomeprazole or to another PPI
• •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. Participation in any study of an investigational treatment in the 4 weeks before Screening
• •4. Presence of uncontrolled acute or chronic medical illness, e.g., GI disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would have endangered a subject if he/she were to participate in the study
• •5. GI disorder or surgery leading to impaired drug absorption
• •6. Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder which in the investigator's opinion would have endangered a subject if he/she were to participate in the study
• •7. Schizophrenia or bipolar disorder
• •8. Use of any excluded concomitant medication
• •9. 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
• •10. Serious blood coagulation disorder, including use of systemic anticoagulants
• •11. Positive test result for Helicobacter pylori at Screening
• •12. Baseline endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth
• •13. Screening laboratory value for any of the following tests that was \> 2 times the upper limit of normal: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
• •14. Estimated creatinine clearance \< 50 mL/min
• •15. 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 subject 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