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

NCT00137033

Last updated date
Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Peptic Ulcers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Peptic UlcersCelebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population NCT00137033
  1. Anaheim, California
  2. San Diego, California
  3. Farmington, Connecticut
  4. Waterbury, Connecticut
  5. Jupiter, Florida
  6. Miami, Florida
  7. Ocoee, Florida
  8. Pembroke Pines, Florida
  9. Chicago, Illinois
  10. Newburgh, Indiana
  11. Davenport, Iowa
  12. Metaire, Louisiana
  13. Chevy Chase, Maryland
  14. New York, New York
  15. Raleigh, North Carolina
  16. Wilmington, North Carolina
  17. Cincinnati, Ohio
  18. Ducansville, Pennsylvania
  19. Chattanooga, Tennessee
  20. Houston, Texas
  21. Houston, Texas
  22. Charlottesville, Virginia
  23. Chesapeake, Virginia
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Peptic Ulcers
Intervention  ICMJE
  • Drug: Celecoxib
  • Drug: Naproxen
  • Drug: ASA
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 26, 2005)
605
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137033
Other Study ID Numbers  ICMJE A3191171
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP