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

First Received on November 12, 2007. Last Updated on November 27, 2007 History of Changes

Sponsor:	University of Missouri-Columbia
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00557349

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/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:

Drug Information available for: Sodium bicarbonate Omeprazole Famotidine Omeprazole magnesium Famotidine hydrochloride Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

No publications provided

ClinicalTrials.gov 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
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Famotidine
Omeprazole
Omeprazole, sodium bicarbonate drug combination
Anti-Ulcer Agents

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on May 22, 2012