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

Condition(s) targeted: Bowel Diseases, Inflammatory

Intervention: Celecoxib (Drug); Placebo (Other); Ibuprofen plus Omeprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: Double-Blind, Placebo-Controlled, Randomized Two-Week Study, Comparing Small Bowel Lesions Associated With Celecoxib (200 mg BID) vs. Ibuprofen (800 mg TID) Plus Omeprazole (20 mg QD)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study

Primary outcome: Number of mucosal breaks in the small bowel for each subject

Secondary outcome:

Adverse events

Laboratory tests

Vital signs

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

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

Change from screening visit in hemoglobin and hematocrit

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

Physical examination

Percentage of subjects with >=1 mucosal breaks

Total number of small bowel lesions with or without hemorrhage

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

Change in Patient General Questionnaire Visual Analog Scale from Day 16

Change in Severity of Dyspepsia Assessment questionnaire from Day 16

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Pfizer Investigational Site, Scottsdale, Arizona 85259, United States

Pfizer Investigational Site, La Jolla, California 92037, United States

Pfizer Investigational Site, Los Angeles, California 90073, United States

Pfizer Investigational Site, LOS ANGELES, California 90033, United States

Pfizer Investigational Site, Jupiter, Florida 33458, United States

Pfizer Investigational Site, Miami, Florida 33173, United States

Pfizer Investigational Site, ROCKFORD, Illinois 61107, United States

Pfizer Investigational Site, Chicago, Illinois 60612, United States

Pfizer Investigational Site, Ann Arbor, Michigan 48109-0362, United States

Pfizer Investigational Site, New York, New York 10021, United States

Pfizer Investigational Site, Portland, Oregon 97239, United States

Pfizer Investigational Site, Nashville, Tennessee 37232-5280, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: October 2003
Ending date: April 2004
Last updated: April 2, 2008