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COMPLETEDPhase 4NCT00640809

Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole

To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole

Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.•12 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Normal, healthy gastrointestinal tract (no small bowel mucosal breaks at Day 14 according to endoscopic data
•No history of GI ulcers, bleeding or surgery, or complete or partial stenosis of the small intestine
•Willing not to drink any alcohol during study period

Exclusion Criteria

•Has established delayed gastric emptying or diabetic gastroparesis
•Has active gastroesophageal reflux disease or requires anti-ulcer medications
•Has taken aspirin or nonsteroidal antinflammatory drugs (ibuprofen, naproxen) more than 3 times per week within 2 weeks prior to the screening visit; aspirin for cardiovascular prophylaxis is restricted

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 2, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment408

Start dateOct 2003

Last updatedFeb 2, 2021

Condition

Bowel Diseases, Inflammatory

Locations shown

Pfizer Investigational Site

Scottsdale, Arizona

Pfizer Investigational Site

La Jolla, California

Pfizer Investigational Site

Los Angeles, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2021Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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