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:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT00175032
Eligibility Criteria:
Inclusion Criteria:
* Must require the chronic use of a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.
* Must be taking daily aspirin for cardiovascular prophylaxis.
* Clinical Laboratory values within normal limits for this population
Exclusion Criteria:
* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
* Evidence of uncontrolled, clinically significant disease.
* History of cancer within the past 5 years.
* Presence of gastroduodenal ulcers, esophageal ulcer or \>= 10 gastroduodenal erosions during the screening endoscopy. Known history of gastroduodenal ulcer or bleeding within the past year. Esophageal stricture requiring dilatation.
* Presence of Barrett's esophagus with dysplastic changes.
* Systemic disease affecting the esophagus or a history of caustic or physiochemical trauma or irradiation to the esophagus.
* Sero-tests positive for H. pylori.
* Evidence of Zollinger-Ellison syndrome, esophageal varices, cholecystitis, or pancreaticobiliary tract disease.
* Requires treatment with an excluded medication such as proton pump inhibitors, histamine H2 receptor antagonists, antacids, corticosteroids, lithium, fluconazole, misoprostol, probenecid, methotrexate, anticoagulants, St. John's wart, dong quai, feverfew, garlic, ginger, horse chestnut, red clover or white willow supplements or bisphosphonates.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00175032
Study Brief:
Protocol Section:
NCT00175032