Clinical trial NCT00175032: A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Peptic Ulcer
Keywords: Low dose aspirin
Peptic Ulcer
gastric ulcer
duodenal ulcer
NSAIDs
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1045
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastroduodenal ulcers at final visit
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction)
timeFrame: Week 12
measure: Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores.
timeFrame: Weeks 4,8, and 12
measure: Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline.
timeFrame: Weeks 4,8, and 12
measure: Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline.
timeFrame: Weeks 4, 8, and 12
measure: Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia.
timeFrame: Weeks 4, 8, and 12
measure: The change from baseline SODA scale for subjects with dyspepsia at baseline.
timeFrame: Weeks 4, 8, and 12
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.cgh.2007.06.009.