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

• Drug: Celecoxib
  
  200 mg oral capsule twice daily for 2 weeks
• Other: Placebo
  
  Matched placebo for 2 weeks
• Drug: Ibuprofen plus Omeprazole
  
  ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks

• Experimental: A
  
  Intervention: Drug: Celecoxib
• Placebo Comparator: B
  
  Intervention: Other: Placebo
• Active Comparator: C
  
  Intervention: Drug: Ibuprofen plus Omeprazole

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