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Ulcer Prevention Study in Post Gastric Bypass Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University of Missouri-Columbia.
Recruitment status was  Active, not recruiting
Information provided by:
University of Missouri-Columbia Identifier:
First received: November 12, 2007
Last updated: November 27, 2007
Last verified: November 2007
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/Sodium Bicarbonate (Zegerid)
Drug: Famotidine (Pepcid)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:
  • Incidence of patient complaints; specifically pain, vomiting, dyspepsia, and/or dysphagia. [ Time Frame: during first 14 weeks after surgery ]

Secondary Outcome Measures:
  • Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints. [ Time Frame: during first 14 weeks after surgery ]

Estimated Enrollment: 40
Study Start Date: November 2006
Estimated Study Completion Date: November 2008
Arms Assigned Interventions
Active Comparator: Drug Arm 1 Drug: Omeprazole/Sodium Bicarbonate (Zegerid)
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: Drug Arm 2 Drug: Famotidine (Pepcid)
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00557349

United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Principal Investigator: Roger de la Torre, MD University of Missouri-Columbia
  More Information Identifier: NCT00557349     History of Changes
Other Study ID Numbers: 1058337 
Study First Received: November 12, 2007
Last Updated: November 27, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
gastric bypass surgery
anastomosis, Roux-en-Y
Complication, Postoperative

Additional relevant MeSH terms:
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
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 processed this record on October 25, 2016