Status:
COMPLETED
Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Bowel Diseases, Inflammatory
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00640809
Start Date
October 1 2003
End Date
April 1 2004
Last Update
February 2 2021
Active Locations (12)
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1
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85259
2
Pfizer Investigational Site
La Jolla, California, United States, 92037
3
Pfizer Investigational Site
Los Angeles, California, United States, 90033
4
Pfizer Investigational Site
Los Angeles, California, United States, 90073