Ulcer Prevention Study in Post Gastric Bypass Patients

University of Missouri (MU)

Status and phase: Completed; Phase 4

Conditions: Marginal Ulcers

Treatments: Drug: Famotidine; Drug: Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00557349

1058337

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Omeprazole

Active Comparator group

Description:

40 mg Omeprazole daily

Treatment:

Drug: Omeprazole

Famotidine

Active Comparator group

Description:

40 mg Famotidine daily

Treatment:

Drug: Famotidine