A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
Osteoarthritis, Peptic Ulcer
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Low dose aspirin, Peptic Ulcer, gastric ulcer, duodenal ulcer, NSAIDs
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Lansoprazole 30 mg QD + Naproxen 500 mg BID
Celecoxib 200 mg QD
(and added aspirin)
(and added aspirin)