A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of Lansoprazole 30 mg QD and Naproxen 500 mg BID Versus Celecoxib 200 mg QD in Risk Reduction of Non Steroidal Anti-Inflammatory-Associated Ulcers in Osteoarthritis Subjects Taking Low Dose Aspirin

NCT00175032 Phase 3 COMPLETED

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.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	1045
Start date	2003-07
Completion	2004-07

Conditions

• Osteoarthritis
• Peptic Ulcer

Interventions

• Lansoprazole and naproxen and aspirin
• Celecoxib and aspirin

Primary outcomes

• Gastroduodenal ulcers at final visit — Week 12