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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,045
Lansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
Gastroduodenal ulcers at final visit
Time frame: Week 12
Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction)
Time frame: Week 12
Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores.
Time frame: Weeks 4,8, and 12
Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline.
Time frame: Weeks 4,8, and 12
Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline.
Time frame: Weeks 4, 8, and 12
Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia.
Time frame: Weeks 4, 8, and 12
The change from baseline SODA scale for subjects with dyspepsia at baseline.
Time frame: Weeks 4, 8, and 12
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