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

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Drug Arm 1
• Active Comparator: Drug Arm 2

Primary Measures

• Incidence of patient complaints; specifically pain, vomiting, dyspepsia, and/or dysphagia.
  • Time Frame: during first 14 weeks after surgery
    

Secondary 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
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Missouri-Columbia

Overall Clinical Trial Officials and Contacts

Roger de la Torre, MD Principal Investigator University of Missouri-Columbia  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00557349

Study ID Number: 1058337

ClinicalTrials.gov Identifier: NCT00557349

Health Authority: United States: Institutional Review Board