Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
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)
1 other identifier
interventional
605
1 country
23
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2004
Shorter than P25 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 26, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedMarch 3, 2021
March 1, 2021
August 26, 2005
March 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Pfizer Investigational Site
Anaheim, California, 92801, United States
Pfizer Investigational Site
San Diego, California, 92123, United States
Pfizer Investigational Site
Farmington, Connecticut, 06030-0001, United States
Pfizer Investigational Site
Waterbury, Connecticut, 06708, United States
Pfizer Investigational Site
Jupiter, Florida, 33458, United States
Pfizer Investigational Site
Miami, Florida, 33173, United States
Pfizer Investigational Site
Ocoee, Florida, 34761, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33024, United States
Pfizer Investigational Site
Chicago, Illinois, 60612-7323, United States
Pfizer Investigational Site
Newburgh, Indiana, 47630, United States
Pfizer Investigational Site
Davenport, Iowa, 52807, United States
Pfizer Investigational Site
Metairie, Louisiana, 70001, United States
Pfizer Investigational Site
Chevy Chase, Maryland, 20815, United States
Pfizer Investigational Site
New York, New York, 10021, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27612, United States
Pfizer Investigational Site
Wilmington, North Carolina, 28401, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Chattanooga, Tennessee, 37404, United States
Pfizer Investigational Site
Houston, Texas, 77074, United States
Pfizer Investigational Site
Houston, Texas, 77090, United States
Pfizer Investigational Site
Charlottesville, Virginia, 22903, United States
Pfizer Investigational Site
Chesapeake, Virginia, 23320-1706, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2005
First Posted
August 29, 2005
Study Start
September 1, 2004
Study Completion
July 1, 2005
Last Updated
March 3, 2021
Record last verified: 2021-03