Ulcer Prevention Study in Post Gastric Bypass Patients

Marginal Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00557349
• Other study ID #: 1058337
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 12, 2007
• Last updated: November 27, 2007
• Start date: November 2006
• Est. completion date: November 2008

Study information

• Verified date: November 2007
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Marginal Ulcers
• Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Missouri Health Care	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of patient complaints; specifically pain, vomiting, dyspepsia, and/or dysphagia.		during first 14 weeks after surgery
Secondary	Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints.		during first 14 weeks after surgery