A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis, Peptic Ulcer

Intervention / Treatment
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* Drug: Lansoprazole and naproxen and aspirin
* Drug: Celecoxib and aspirin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lansoprazole 30 mg QD + Naproxen 500 mg BID<br>(and added aspirin) | Drug: Lansoprazole and naproxen and aspirin<br>* 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.<br>|
| Active Comparator: Celecoxib 200 mg QD<br>(and added aspirin) | Drug: Celecoxib and aspirin<br>* Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroduodenal ulcers at final visit |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction) |  | Week 12 | 
| 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 without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline. |  | Weeks 4, 8, and 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low dose aspirin, Peptic Ulcer, gastric ulcer, duodenal ulcer, NSAIDs