To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus...
Date First Received: March 17, 2008
Last Updated: April 2, 2008
Verified by: Pfizer, March 2008
Clinical Trial Phase: Phase 4 | Start Date: October 2003
Overall Status: Completed
Estimated Enrollment: 408
Brief Summary
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)”
Condition Keyword(s):
Intervention(s):
To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Outcome Measures for this Clinical Trial
Primary:
- Number of mucosal breaks in the small bowel for each subject Day 30 Yes
Secondary:
- Adverse events Day 30 Yes
- Laboratory tests Day 30 Yes
- Vital signs Day 30 Yes
- Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test Day 30 Yes
- Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks Day 30 Yes
- Change from screening visit in hemoglobin and hematocrit Day 30 Yes
- Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks Day 30 Yes
- Physical examination Day 30 Yes
- Percentage of subjects with >=1 mucosal breaks Day 30 Yes
- Total number of small bowel lesions with or without hemorrhage Day 30 Yes
- Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel) Day 30 Yes
- Change in Patient General Questionnaire Visual Analog Scale from Day 16 Day 30 Yes
- Change in Severity of Dyspepsia Assessment questionnaire from Day 16 Day 30 Yes
Criteria for Participation in this Clinical Trial
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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Pfizer
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
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640809
Study ID Number: A3191071
ClinicalTrials.gov Identifier: NCT00640809
Health Authority: United States: Food and Drug Administration
To obtain contact information for a study center near you, click here.
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
