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Ulcer Prevention Study in Post Gastric Bypass Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00557349
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Marginal Ulcers Drug: Omeprazole Drug: Famotidine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind Clinical Trial Comparing Zegerid Capsule to Famotidine in Preventing Anastomotic (Marginal) Ulcers in Post Gastric Bypass Patients
Study Start Date : November 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Omeprazole
40 mg Omeprazole daily
 Drug: Omeprazole
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.
Other Name: Zegerid
Active Comparator: Famotidine
40 mg Famotidine daily
 Drug: Famotidine
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.
Other Name: Pepcid


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. [ Time Frame: during first 14 weeks after surgery ]

Secondary Outcome Measures :
  1. Number of Participants With Upper Endoscopy Indicated Due to Complaints [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557349


Locations
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United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Roger de la Torre, MD University of Missouri-Columbia
More Information
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Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00557349    
Other Study ID Numbers: 1058337
First Posted: November 14, 2007    Key Record Dates
Results First Posted: January 19, 2017
Last Update Posted: January 19, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Missouri-Columbia:
gastric bypass surgery
anastomosis, Roux-en-Y
Complication, Postoperative
Additional relevant MeSH terms:
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Peptic Ulcer
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Omeprazole
Famotidine
 Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs