Status:
COMPLETED
A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
Lead Sponsor:
Takeda
Conditions:
Osteoarthritis
Peptic Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, napro...
Detailed Description
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 osteoar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
1045 Patients enrolled
Trial Details
Trial ID
NCT00175032
Start Date
July 1 2003
End Date
July 1 2004
Last Update
July 22 2010
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