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