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Completed Phase 4 Interventional Accepts healthy volunteers

Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population

ClinicalTrials.gov ID: NCT00137033

Public ClinicalTrials.gov record NCT00137033. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 4:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00137033
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
605 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
50 Years to 75 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2004 (Type not available)
Primary completion
Not listed
Completion
Jul 2005 (Actual)
Last update posted
Mar 3, 2021

2004 – 2005

United States locations

U.S. sites
23
U.S. states
15
U.S. cities
22
Facility City State ZIP Site status
Pfizer Investigational Site Anaheim California 92801 —
Pfizer Investigational Site San Diego California 92123 —
Pfizer Investigational Site Farmington Connecticut 06030-0001 —
Pfizer Investigational Site Waterbury Connecticut 06708 —
Pfizer Investigational Site Jupiter Florida 33458 —
Pfizer Investigational Site Miami Florida 33173 —
Pfizer Investigational Site Ocoee Florida 34761 —
Pfizer Investigational Site Pembroke Pines Florida 33024 —
Pfizer Investigational Site Chicago Illinois 60612-7323 —
Pfizer Investigational Site Newburgh Indiana 47630 —
Pfizer Investigational Site Davenport Iowa 52807 —
Pfizer Investigational Site Metairie Louisiana 70001 —
Pfizer Investigational Site Chevy Chase Maryland 20815 —
Pfizer Investigational Site New York New York 10021 —
Pfizer Investigational Site Raleigh North Carolina 27612 —
Pfizer Investigational Site Wilmington North Carolina 28401 —
Pfizer Investigational Site Cincinnati Ohio 45219 —
Pfizer Investigational Site Duncansville Pennsylvania 16635 —
Pfizer Investigational Site Chattanooga Tennessee 37404 —
Pfizer Investigational Site Houston Texas 77074 —
Pfizer Investigational Site Houston Texas 77090 —
Pfizer Investigational Site Charlottesville Virginia 22903 —
Pfizer Investigational Site Chesapeake Virginia 23320-1706 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00137033, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 3, 2021 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00137033 live on ClinicalTrials.gov.

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