Ulcer Prevention Study in Post Gastric Bypass Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-blind Clinical Trial Comparing Zegerid Capsule to Famotidine in Preventing Anastomotic (Marginal) Ulcers in Post Gastric Bypass Patients

Conditions
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Marginal Ulcers

Intervention / Treatment
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* Drug: Omeprazole
* Drug: Famotidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omeprazole<br>40 mg Omeprazole daily | Drug: Omeprazole<br>* 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.<br>* Other names: Zegerid;|
| Active Comparator: Famotidine<br>40 mg Famotidine daily | Drug: Famotidine<br>* 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.<br>* Other names: Pepcid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. |  | during first 14 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during first 14 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric bypass surgery, anastomosis, Roux-en-Y, Complication, Postoperative