Chemoprevention of Gastric Cancer by Intervention With Helicobacter Pylori and Cyclooxygenase Pathway
1. Subject demonstrates a willingness to participate in the study as indicated by
written informed consent.
2. Male or female subject is at least 45 years of age.
3. Subject indicates a willingness to abstain from the use of all NSAIDs (including
over-the-counter products) and aspirin for the duration of the study.
4. Female subject of childbearing potential has been using an effective means of
contraception for 1 week prior to the preliminary visit. She also has agreed to
remain abstinent, or to use oral birth control pills or single-barrier contraception
(partner using condom or subject using diaphragm, contraceptive sponge or IUD)
beginning at the preliminary visit and continuing till the end of the study. Women
who are postmenopausal or status post-hysterectomy or tubal ligation are exempt from
this requirement. (Postmenopausal is defined as no menses for the previous 1 year. If
cessation of menses is within 18 months, FSH must be documented as elevated into the
postmenopausal range before entry).
5. Subject is judged to be in stable health based on medical history, physical
examination, and routine laboratory tests.
According to medical history
1. Subject has a bleeding diathesis or requires anticoagulant therapy.
2. Subject has uncontrolled hypertension. (Note: Subjects with medically controlled
hypertension [diastolic blood pressure <95 mm Hg, systolic blood pressure <165 mm Hg]
3. Subject has a history of stroke or transient ischemic attack within the past 2 years.
4. Subject has a history of hepatitis/hepatic disease that has been active within the
previous 2 years.
5. Subject has angina or congestive heart failure, with symptoms that occur at rest or
minimal activity, or has a history of myocardial infarction within the past 1 year.
6. Subject has a history of neoplastic disease within the previous 10 years. Exceptions:
subjects with malignancy successfully treated >10 years prior to screening, where, in
the judgment of the investigator and treating physician, there has been no evidence
of recurrence from the time of treatment through the time of screening.
7. Subject has a history of esophageal or gastric surgery.
8. Subject has undergone previous small or large bowel resection.
9. Subject has a history of inflammatory bowel disease (ulcerative colitis or Crohn's
10. Subject is allergic to paracetamol or subject has hypersensitivity (e.g., all or part
of the syndrome of nasal polyps, angioedema, and bronchospastic reactivity) to
aspirin, paracetamol, or other NSAIDs. NOTE: Subjects with a history of idiosyncratic
allergic reaction (e.g., rash) to a single NSAID in the past but who tolerated at
least 2 other NSAID medications without hypersensitivity reactions may participate.
11. Subject is expected to need chronic NSAID treatment during the trial and/or subject
has been taking NSAIDs (including salicylates or other aspirin-containing compounds)
on a chronic basis.
12. Subject has had ongoing or is expected to require treatment with any of the
following: Ticlopidine, clopidrogel, or regular doses of aspirin, including
"low-dose" aspirin, e.g., to prevent complications of vascular disease. Subjects may
not discontinue an established course of anti-platelet therapy in order to enter this