Phase 4 N=40 Randomized Double-blind Prevention

Ulcer Prevention Study in Post Gastric Bypass Patients

Marginal Ulcers

Bottom Line

View on ClinicalTrials.gov: NCT00557349 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. — 17; 13 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Omeprazole (Drug); Famotidine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Missouri-Columbia
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.	17; 13	—
SECONDARY Number of Participants With Upper Endoscopy Indicated Due to Complaints	1; 13	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00557349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.