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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


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
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