Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00498134
Eligibility Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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 \[diastolic blood pressure \<95 mm Hg, systolic blood pressure \<165 mm Hg\] may participate.)
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 disease).
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 study.
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT00498134
Study Brief:
Protocol Section:
NCT00498134