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)

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 Overview

• Status: Completed
• Conditions: Peptic Ulcers
• Intervention / Treatment: Drug: Celecoxib; Drug: Naproxen; Drug: ASA

• Study Type: Interventional
• Enrollment: 605
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Pfizer Investigational Site
    • San Diego, California, United States, 92123
      • Pfizer Investigational Site
  • Connecticut
    • Farmington, Connecticut, United States, 06030-0001
      • Pfizer Investigational Site
    • Waterbury, Connecticut, United States, 06708
      • Pfizer Investigational Site
  • Florida
    • Jupiter, Florida, United States, 33458
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33173
      • Pfizer Investigational Site
    • Ocoee, Florida, United States, 34761
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States, 33024
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612-7323
      • Pfizer Investigational Site
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Pfizer Investigational Site
  • Iowa
    • Davenport, Iowa, United States, 52807
      • Pfizer Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Pfizer Investigational Site
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10021
      • Pfizer Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Pfizer Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Pfizer Investigational Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Pfizer Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Pfizer Investigational Site
  • Texas
    • Houston, Texas, United States, 77074
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77090
      • Pfizer Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Pfizer Investigational Site
    • Chesapeake, Virginia, United States, 23320-1706
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: August 26, 2005
• First Submitted That Met QC Criteria: August 26, 2005
• First Posted (Estimate): August 29, 2005

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Gout Suppressants; Celecoxib; Naproxen
• Other Study ID Numbers: A3191171