Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

Exclusion Criteria

• •History of hypersensitivity to omeprazole or to another proton-pump inhibitor.
• •History of allergic reaction or intolerance to any NSAID (including aspirin) and/or subject has a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps.
• •Participation in any study of an investigational treatment in the 4 weeks before screening.
• •Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, diabetes, hypertension, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study.
• •Gastrointestinal disorder or surgery leading to impaired drug absorption.
• •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.
• •Schizophrenia or bipolar disorder.
• •Use of any excluded concomitant medication (see Section 9.2).
• •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.
• •Serious blood coagulation disorder including use of systemic anticoagulants.
• •Positive test result for H. pylori at screening.
• •Baseline endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth.
• •Screening laboratory value for ALT, AST \>2 times the upper limit of normal.
• •Estimated creatinine clearance \< 30 ml/min.
• •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.
• •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.