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

Primary Purpose

Peptic Ulcers

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Naproxen
ASA
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peptic Ulcers

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
August 26, 2005
Last Updated
March 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00137033
Brief Title
Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
605 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Type
Drug
Intervention Name(s)
ASA
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-0001
Country
United States
Facility Name
Pfizer Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Pfizer Investigational Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
Country
United States
Facility Name
Pfizer Investigational Site
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Pfizer Investigational Site
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Pfizer Investigational Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Pfizer Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Pfizer Investigational Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320-1706
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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