Overview

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

Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Celecoxib
Ibuprofen
Omeprazole
Criteria
Inclusion Criteria:

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:

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