Intervention: Naproxen
Trial phase: Phase 3
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 216
Group description: Naproxen 500 mg
Eligibility criteria:
Inclusion Criteria

A subject was eligible for inclusion in this study if all of the following criteria applied:

Male or non-pregnant, non-breastfeeding 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 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.)

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

Exclusion Criteria

A subject was not eligible for this study if any 1 or more of the following criteria applied:

History of hypersensitivity to esomeprazole or to another PPI
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
Participation in any study of an investigational treatment in the 4 weeks before Screening
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 they were to have participated in the study
GI disorder or surgery leading to impaired drug absorption
Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would have endangered a subject if they were to have participated in the study
Schizophrenia or bipolar disorder
Use of any excluded concomitant medication (see Section 9.4.8)
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
Screening endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth
Screening laboratory alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 2 times the upper limit of normal
Estimated creatinine clearance < 30 ml/min
Other than noted specifically, any screening laboratory value that was clinically significant in the investigator's opinion and would have endangered a subject if they were to have participated 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