Ulcer Prevention Study in Post Gastric Bypass Patients

Phase 4

Completed

• Conditions: Marginal Ulcers
• Interventions: Drug: Omeprazole; Drug: Famotidine

• Registration Number: NCT00557349
• Lead Sponsor: University of Missouri-Columbia

Brief 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.

Detailed Description

The purpose of this research is to evaluate information about the control of gastric acid in post gastric bypass surgery patients. Goal is to determine which medication best reduces the incidence of anastomotic ulcers post-operatively.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-11
• Study First Submitted: 2007-11-12
• Study First Submitted QC: 2007-11-12
• Study First Posted: 2007-11-14
• Study Completion: 2008-03
• Results First Submitted: 2009-02-27
• Status Verified: 2016-09
• Results First Submitted QC: 2016-11-22
• Last Update Submitted: 2016-11-22
• Results First Posted: 2017-01-19
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omeprazole	Omeprazole	40 mg Omeprazole daily
Famotidine	Famotidine	40 mg Famotidine daily

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.	during first 14 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Upper Endoscopy Indicated Due to Complaints	during first 14 weeks after surgery	Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints

Trial Locations

Locations (1)

University of Missouri Health Care; 🇺🇸 Columbia, Missouri, United States