Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00137033
Collaborator
(none)
605
23
10
26.3
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Study Details
Study Description
Brief Summary
The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
A Multicenter, Randomized, Active-Controlled Comparison Study of the Incidence of Gastroduodenal Ulcers Associated With Celecoxib and Low Dose ASA Versus Naproxen and Low Dose ASA in Healthy Subjects (50-75 Years of Age)
Study Start Date
:
Sep 1, 2004
Actual Study Completion Date
:
Jul 1, 2005
Outcome Measures
Primary Outcome Measures
- Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib 200 mg QD plus ASA 81 mg QD vs. naproxen 500 mg BID plus ASA 81 mg QD in healthy subjects (50-75 years old). []
Secondary Outcome Measures
- Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib plus ASA vs placebo plus ASA in healthy subjects (50-75 years of age) Compare the incidence of gastroduodenal endoscopic ulcers between naproxen plus ASA vs. placebo plus ASA []
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- A healthy adult between 50 and 75 years of age inclusive: of normal clinical laboratory test results during the Screening Visit or, if abnormal, are not clinically significant in the Investigator's opinion.
Exclusion Criteria:
- A gastric, pyloric channel or duodenal ulcer (defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than 5 erosions in the stomach or duodenum ( the UGI endoscopic score greater or less) on the baseline UGI endoscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Anaheim | California | United States | 92801 |
| 2 | Pfizer Investigational Site | San Diego | California | United States | 92123 |
| 3 | Pfizer Investigational Site | Farmington | Connecticut | United States | 06030-0001 |
| 4 | Pfizer Investigational Site | Waterbury | Connecticut | United States | 06708 |
| 5 | Pfizer Investigational Site | Jupiter | Florida | United States | 33458 |
| 6 | Pfizer Investigational Site | Miami | Florida | United States | 33173 |
| 7 | Pfizer Investigational Site | Ocoee | Florida | United States | 34761 |
| 8 | Pfizer Investigational Site | Pembroke Pines | Florida | United States | 33024 |
| 9 | Pfizer Investigational Site | Chicago | Illinois | United States | 60612-7323 |
| 10 | Pfizer Investigational Site | Newburgh | Indiana | United States | 47630 |
| 11 | Pfizer Investigational Site | Davenport | Iowa | United States | 52807 |
| 12 | Pfizer Investigational Site | Metairie | Louisiana | United States | 70001 |
| 13 | Pfizer Investigational Site | Chevy Chase | Maryland | United States | 20815 |
| 14 | Pfizer Investigational Site | New York | New York | United States | 10021 |
| 15 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27612 |
| 16 | Pfizer Investigational Site | Wilmington | North Carolina | United States | 28401 |
| 17 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45219 |
| 18 | Pfizer Investigational Site | Duncansville | Pennsylvania | United States | 16635 |
| 19 | Pfizer Investigational Site | Chattanooga | Tennessee | United States | 37404 |
| 20 | Pfizer Investigational Site | Houston | Texas | United States | 77074 |
| 21 | Pfizer Investigational Site | Houston | Texas | United States | 77090 |
| 22 | Pfizer Investigational Site | Charlottesville | Virginia | United States | 22903 |
| 23 | Pfizer Investigational Site | Chesapeake | Virginia | United States | 23320-1706 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00137033
Other Study ID Numbers:
- A3191171
First Posted:
Aug 29, 2005
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021