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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137033
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 16, 2008
Sponsor:
Information provided by:
Pfizer

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).

Condition or disease Intervention/treatment Phase
Peptic Ulcers Drug: Celecoxib Drug: Naproxen Drug: ASA Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : September 2004
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer




Primary Outcome Measures :
  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 Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137033


Locations
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United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States, 06030-0001
Pfizer Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Pfizer Investigational Site
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
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612-7323
United States, Indiana
Pfizer Investigational Site
Newburgh, Indiana, United States, 47630
United States, Iowa
Pfizer Investigational Site
Davenport, Iowa, United States, 52807
United States, Louisiana
Pfizer Investigational Site
Metaire, Louisiana, United States, 70001
United States, Maryland
Pfizer Investigational Site
Chevy Chase, Maryland, United States, 20815
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
Pfizer Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Pfizer Investigational Site
Ducansville, Pennsylvania, United States, 16635
United States, Tennessee
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37404
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77074
Pfizer Investigational Site
Houston, Texas, United States, 77090
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22903
Pfizer Investigational Site
Chesapeake, Virginia, United States, 23320-1706
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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ClinicalTrials.gov Identifier: NCT00137033    
Other Study ID Numbers: A3191171
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: July 16, 2008
Last Verified: September 2007
Additional relevant MeSH terms:
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Peptic Ulcer
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Celecoxib
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants