Official Title: “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”

The objective of this study is to compare the gastroduodenal ulceration rate, and gastrointestinal (GI) complication rate and non-steroidal anti-inflammatory drug (NSAID)-associated dyspepsia between lansoprazole 30 mg QD and naproxen 500 mg BID and celecoxib 200 mg QD in osteoarthritis (OA) subjects taking low dose aspirin at the end of the 12 weeks of treatment.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Primary:

• Gastroduodenal ulcers at final visit Week 12 No

Secondary:

• Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction) Week 12 No
• Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores. Weeks 4,8, and 12 No
• Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline. Weeks 4,8, and 12 No
• Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline. Weeks 4, 8, and 12 No
• Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia. Weeks 4, 8, and 12 No
• The change from baseline SODA scale for subjects with dyspepsia at baseline. Weeks 4, 8, and 12 No

Inclusion Criteria:

• Must require the chronic use of an NSAID 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.

Lead Sponsor: TAP Pharmaceutical Products Inc.

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair TAP Pharmaceutical Products Inc.  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00175032

Study ID Number: LAN-0003-0041

ClinicalTrials.gov Identifier: NCT00175032

Health Authority: United States: Food and Drug Administration

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