Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
NCT00137033
Last updated date
ABOUT THIS STUDY
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 Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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
- Anaheim, California
- San Diego, California
- Farmington, Connecticut
- Waterbury, Connecticut
- Jupiter, Florida
- Miami, Florida
- Ocoee, Florida
- Pembroke Pines, Florida
- Chicago, Illinois
- Newburgh, Indiana
- Davenport, Iowa
- Metaire, Louisiana
- Chevy Chase, Maryland
- New York, New York
- Raleigh, North Carolina
- Wilmington, North Carolina
- Cincinnati, Ohio
- Ducansville, Pennsylvania
- Chattanooga, Tennessee
- Houston, Texas
- Houston, Texas
- Charlottesville, Virginia
- 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 |
| |||
| 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 | 605 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | July 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||