Ulcer Prevention Study in Post Gastric Bypass Patients
Information source: University of Missouri-Columbia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Marginal Ulcers
Intervention: Omeprazole/Sodium Bicarbonate (Zegerid) (Drug); Famotidine (Pepcid) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Missouri-Columbia Official(s) and/or principal investigator(s):
Roger de la Torre, MD, Principal Investigator, Affiliation: University of Missouri-Columbia
Summary
This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or
Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer
after gastric bypass surgery.
Clinical Details
Official title: A Randomized, Double-Blind Clinical Trial Comparing Zegerid Capsule to Famotidine in Preventing Anastomotic (Marginal) Ulcers in Post Gastric Bypass Patients
Study design: Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Incidence of patient complaints; specifically pain, vomiting, dyspepsia, and/or dysphagia.
Secondary outcome: Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is age ≥ 18 years
- Patient meets the criteria for laparoscopic gastric bypass surgery
- Females only: Patient is willing to take a urine pregnancy test
Exclusion Criteria:
- Subject allergic to omeprazole or famotidine
- Patient receiving antifungal (i. e. ketoconazole or itraconazole)
- Hepatic insufficiency
- History of Crohns disease
- History of Zollinger-Ellison disease
- Patient received an investigational drug within 30 days of enrollment
- Patient currently enrolled in another research project
- Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks
Locations and Contacts
University of Missouri Health Care, Columbia, Missouri 65212, United States
Additional Information
Starting date: November 2006
Ending date: November 2008
Last updated: November 27, 2007
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