The purpose of this study is 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.
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.
