Osteoarthritis Clinical Trial
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
Verified date | July 2010 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1045 |
Est. completion date | July 2004 |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Takeda |
Goldstein JL, Cryer B, Amer F, Hunt B. Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1167-74. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores. | Weeks 4,8, and 12 | No | |
Secondary | Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline. | Weeks 4,8, and 12 | No | |
Secondary | Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline. | Weeks 4, 8, and 12 | No | |
Secondary | Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia. | Weeks 4, 8, and 12 | No | |
Secondary | The change from baseline SODA scale for subjects with dyspepsia at baseline. | Weeks 4, 8, and 12 | No |
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