Back to resultsUlcer Prevention Study in Post Gastric Bypass Patients
Primary Purpose
Marginal Ulcers
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omeprazole
Famotidine
Sponsored by
About this trial
This is an interventional prevention trial for Marginal Ulcers focused on measuring gastric bypass surgery, anastomosis, Roux-en-Y, Complication, Postoperative
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
Sites / Locations
- University of Missouri Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Omeprazole
Famotidine
Arm Description
40 mg Omeprazole daily
40 mg Famotidine daily
Outcomes
Primary Outcome Measures
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
Secondary Outcome Measures
Number of Participants With Upper Endoscopy Indicated Due to Complaints
Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints
Full Information
NCT ID
NCT00557349
First Posted
November 12, 2007
Last Updated
November 22, 2016
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00557349
Brief Title
Ulcer Prevention Study in Post Gastric Bypass Patients
Official Title
A Randomized, Double-blind Clinical Trial Comparing Zegerid Capsule to Famotidine in Preventing Anastomotic (Marginal) Ulcers in Post Gastric Bypass Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Ulcers
Keywords
gastric bypass surgery, anastomosis, Roux-en-Y, Complication, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omeprazole
Arm Type
Active Comparator
Arm Description
40 mg Omeprazole daily
Arm Title
Famotidine
Arm Type
Active Comparator
Arm Description
40 mg Famotidine daily
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Zegerid
Intervention Description
40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
Intervention Type
Drug
Intervention Name(s)
Famotidine
Other Intervention Name(s)
Pepcid
Intervention Description
40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
Primary Outcome Measure Information:
Title
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
Time Frame
during first 14 weeks after surgery
Secondary Outcome Measure Information:
Title
Number of Participants With Upper Endoscopy Indicated Due to Complaints
Description
Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints
Time Frame
during first 14 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger de la Torre, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ulcer Prevention Study in Post Gastric Bypass Patients
We'll reach out to this number within 24 hrs