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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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

NCT00137033
Pfizer
Completed
Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population

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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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Peptic Ulcers
  • Drug: Celecoxib
  • Drug: Naproxen
  • Drug: ASA
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
605
July 2005
Not Provided

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
Sexes Eligible for Study: All
50 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00137033
A3191171
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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