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

This is an interventional treatment trial for Gastric Ulcer focused on measuring NSAID, Gastric Ulcer, High risk, Arthrotec, Vimovo Read More

Inclusion Criteria:

1. Male or non-pregnant female subjects, 18 years and older with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical condition expected to require daily NSAID therapy for at least 6 months, with a documented history of an ulcer related serious upper gastrointestinal event such as bleeding, perforation or obstruction

2. Female subjects are eligible for participation in the study if they are of:

   • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);

   • Childbearing potential, have a negative pregnancy test at screening, and at least one of the following applies or is agreed to by the subject:

     • Female sterilization or sterilization of male partner; or,
     • Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
     • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year;
     • Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or
     • Any other method with published data showing that the lowest expected failure rate is less than 1% per year
3. Each subject must be able to understand and comply with study procedures required of a subject and is able and willing to provide written informed consent prior to any study procedures being performed

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