Clinical trial NCT00367211 (phase 3, status: completed)
Conditions: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis
ICD codes: M15.4, M15.0, M16.9, M17.9, M19.011, M19.012, M19.019, M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019, M08.1, M45.6, M45.2, M45.3, M45.4, M45.5, M45.7
Drugs: pn 200 tablets (500 mg naproxen and 20 mg omeprazole), naproxen 500 mg tablets (pn 200 minus omeprazole)
SMILES: COC1=CC2=C(C=C1)C=C(C=C2)[C@H](C)C(O)=O, COC1=CC2=C(C=C1)C=C(C=C2)[C@H](C)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  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 6 months who are 18-49 years of age and have 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 are 50 years of age and older (these
             subjects do not require a history of a documented, uncomplicated gastric or duodenal
             ulcer within the past 5 years).

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

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

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

                    -  Complete abstinence from intercourse for at least 14 days prior to first
                       dose of study drug, throughout the study, and for 30 days after completion
                       of the study

                    -  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.

          -  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:

          -  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.