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

Completed · Phase 4 · Has a placebo group

Conditions studied: Bowel Diseases, Inflammatory

In brief

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

Key facts

Study ID

NCT00640809

Run by

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

People needed

408

Starts

2003-10-01

Expected to finish

2004-04-01

Last updated by the study team

2021-02-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Jupiter, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Rockford, Illinois, United States
• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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