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

Phase 4CompletedNCT00640809

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.408 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

408

Conditions

Bowel Diseases, Inflammatory

Interventions

CelecoxibDRUG

200 mg oral capsule twice daily for 2 weeks

PlaceboOTHER

Matched placebo for 2 weeks

Ibuprofen plus OmeprazoleDRUG

ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (12)

Pfizer Investigational Site

Scottsdale, Arizona, United States

Pfizer Investigational Site

La Jolla, California, United States

Pfizer Investigational Site

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of mucosal breaks in the small bowel for each subject

Time frame: Day 30

Secondary Outcomes

Adverse events

Time frame: Day 30

Laboratory tests

Time frame: Day 30

Vital signs

Time frame: Day 30

Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test

Time frame: Day 30

Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks

Time frame: Day 30

Change from screening visit in hemoglobin and hematocrit

Time frame: Day 30

Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks

Time frame: Day 30

Physical examination

Time frame: Day 30

Percentage of subjects with >=1 mucosal breaks

Time frame: Day 30

Total number of small bowel lesions with or without hemorrhage

Time frame: Day 30

Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.