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OpenTrials
Completed

NCT Number: NCT00137033

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

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).

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Key information

Conditions

Peptic Ulcers Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Naproxen

Drug

ASA

Drug

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Study completion
2005
First posted
Aug 29, 2005
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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