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

Viatris

Status and phase: Completed; Phase 4

Conditions: Bowel Diseases, Inflammatory

Treatments: Drug: Ibuprofen plus Omeprazole; Drug: Celecoxib; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640809

A3191071

Details and patient eligibility

About

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

Enrollment: 408 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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408 participants in 3 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Celecoxib

B

Placebo Comparator group

Treatment:

Other: Placebo

C

Active Comparator group

Treatment:

Drug: Ibuprofen plus Omeprazole