Original articlesVideo capsule endoscopy to prospectively assess small bowel injury with celecoxib, naproxen plus omeprazole, and placebo
Section snippets
Patients and methods
Healthy adults (18–70 years of age) who had no evidence of either a mucosal break or blood in the small bowel at the baseline VCE and who had no clinically significant laboratory or physical examination abnormalities were eligible for randomization. Important criteria for exclusion were active gastrointestinal disease or history of gastrointestinal ulcers or bleeding; known or suspected complete or partial stenosis of the small intestine; prior gastric or intestinal surgery (resection);
Patients
Between September 2002 and March 2003, we screened 462 healthy adult subjects from 9 centers (8 centers in the United States and 1 center in Israel). A total of 40 subjects did not meet general inclusion and/or exclusion criteria, and in 9 other subjects the baseline videos were technical failures. Of the remaining 413 subjects, 57 (13.8%) were found to have lesions at the baseline VCE and were not eligible for randomization. The remaining 356 subjects underwent randomization: 120 to celecoxib,
Discussion
We found a 9-fold lower mean number of small bowel mucosal breaks per subject in healthy individuals who received 2 weeks of treatment with celecoxib 200 mg twice daily compared to the combination of naproxen 500 mg twice daily plus omeprazole 20 mg once daily (0.32 vs 2.99; P < .001). The celecoxib group also had a significantly smaller percentage of subjects with mucosal breaks (16% vs 55%, P < .001). In addition, in our post hoc analysis among subjects who developed at least 1 mucosal break,
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Individual investigators are listed in the Appendix.
Supported by a grant from Pharmacia Corporation and Pfizer, Inc.
- 1
Drs Goldstein and Eisen are consultants to Pfizer and have received travel expenses and honoraria
- 2
Dr. Lewis is a consultant to Pfizer and has received travel expenses. He is also a member of the Medical Advisory Board for Given Imaging, Ltd, and has received honoraria
- 3
Dr Gralnek is a consultant to Pfizer and has received honoraria and travel expenses and is supported by a VA HSR&D advanced research career development award
- 4
Drs Zlotnick and Fort are former employees of Pfizer, Inc.