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Ulcer Prevention Study in Post Gastric Bypass Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00557349
First received: November 12, 2007
Last updated: November 22, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Marginal Ulcers
Drug: Omeprazole
Drug: Famotidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

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

Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: November 2006
Study Completion Date: March 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557349

Locations
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Roger de la Torre, MD University of Missouri-Columbia
  More Information

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00557349     History of Changes
Other Study ID Numbers: 1058337
Study First Received: November 12, 2007
Results First Received: February 27, 2009
Last Updated: November 22, 2016
Individual Participant Data  
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:
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Omeprazole
Famotidine
Omeprazole, sodium bicarbonate drug combination
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

ClinicalTrials.gov processed this record on March 29, 2017