Osteoarthritis, Peptic Ulcer
Conditions
Keywords
Low dose aspirin, Peptic Ulcer, gastric ulcer, duodenal ulcer, NSAIDs
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, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.
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 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.
Interventions
DRUGLansoprazole and naproxen and aspirin
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.
DRUGCelecoxib and aspirin
Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastroduodenal ulcers at final visit | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores. | Weeks 4,8, and 12 |
| Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline. | Weeks 4,8, and 12 |
| Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction) | Week 12 |
| Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia. | Weeks 4, 8, and 12 |
| The change from baseline SODA scale for subjects with dyspepsia at baseline. | Weeks 4, 8, and 12 |
| Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline. | Weeks 4, 8, and 12 |
Outcome results
None listed