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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175032
• Other study ID #: LAN-0003-0041
• Secondary ID: U1111-1114-2275
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: July 20, 2010
• Start date: July 2003
• Est. completion date: July 2004

Study information

• Verified date: July 2010
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Peptic Ulcer
• Ulcer

Intervention

Drug:
• Lansoprazole and naproxen and aspirin
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.
• Celecoxib and aspirin
Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

References & Publications (1)

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

Outcome

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

External Links

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