A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)
Condition: Gastric Ulcer
MeSH terms: Stomach Ulcer
Intervention: PN400 (VIMOVO); PN 400 (VIMOVO)
Intervention description: Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed.; 500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months
Intervention MeSH terms: Naproxen; Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: osteoarthritis; rheumatoid arthritis; ankylosing spondylisit; NSAIDS

Summary:

      This study uses an open-label design and will be conducted in approximately 60 sites aiming
      to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12
      months exposure to PN400 (VIMOVO).
    

Eligibility criteria:

        Inclusion Criteria

        A subject was eligible for inclusion in this study if all of the following criteria
        applied:

          1. Male or non-pregnant female subjects with a history of osteoarthritis, rheumatoid
             arthritis, ankylosing spondylitis or other medical conditions expected to require
             daily NSAID therapy for at least 12 months:

             who were

               -  18-49 years of age and had a history of a documented, uncomplicated gastric or
                  duodenal ulcer (a mucosal break of at least 3 mm in diameter with depth, without
                  any concurrent bleeding, clot or perforation) within the past 5 years or, who
                  were

               -  50 years of age and older (These subjects did not require a history of a
                  documented, uncomplicated gastric or duodenal ulcer within the past 5 years).

          2. Female subjects were eligible for participation in the study if they were of

               -  Non-childbearing potential (i.e., physiologically incapable of becoming
                  pregnant);

               -  Childbearing potential, had negative pregnancy test at Screening, and at least 1
                  of the following applied or was 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 with published data showing that the lowest expected
                  failure rate is less than 1% per year; or,

               -  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 was required to be able and willing to provide written informed consent
             prior to any study procedures being performed.

        Exclusion Criteria

        A subject was not eligible for inclusion in this study if any 1 or more of the following
        criteria applied:

          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