A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal
 complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between
 lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in
 participants with osteoarthritis taking low dose aspirin.
This study was designed to compare the effectiveness of reducing the incidence of
 gastroduodenal ulcers between lansoprazole 30mg QD + naproxen 500mg BID vs celecoxib 200mg QD
 in subjects with osteoarthritis taking low dose aspirin. Approximately 100 sites across the
 U.S. will enroll subjects with normal endoscopic findings and negative H.pylori. The duration
 of the study will be a maximum of 14 weeks including a screening period of up to 2 weeks and
 a 12 week treatment period. Gelusil will be provided for dyspepsia symptom rescue.
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.