Status:

COMPLETED

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

Lead Sponsor:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Conditions:

Peptic Ulcers

Eligibility:

All Genders

50-75 years

Phase:

PHASE4

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 25...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

End Date :

July 1 2005

Estimated Enrollment :

605 Patients enrolled

Trial Details

Trial ID

NCT00137033

Start Date

September 1 2004

End Date

July 1 2005

Last Update

March 3 2021

Active Locations (23)

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Page 1 of 6 (23 locations)

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