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

Phase 3

Completed

• Conditions: Osteoarthritis; Peptic Ulcer
• Interventions: Drug: Lansoprazole and naproxen and aspirin; Drug: Celecoxib and aspirin

• Registration Number: NCT00175032
• Lead Sponsor: Takeda

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-20
• Last Update Posted: 2010-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1045

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lansoprazole 30 mg QD + Naproxen 500 mg BID	Lansoprazole and naproxen and aspirin	(and added aspirin)
Celecoxib 200 mg QD	Celecoxib and aspirin	(and added aspirin)

Primary Outcome Measures

Name	Time	Method
Gastroduodenal ulcers at final visit	Week 12

Secondary Outcome Measures

Name	Time	Method
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