Overview

This trial is active, not recruiting.

Condition marginal ulcers
Treatments omeprazole/sodium bicarbonate (zegerid), famotidine (pepcid)
Phase phase 4
Sponsor University of Missouri-Columbia
Start date November 2006
End date November 2008
Trial size 40 participants
Trial identifier NCT00557349, 1058337

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
omeprazole/sodium bicarbonate (zegerid) 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.
(Active Comparator)
famotidine (pepcid) 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.

Primary Outcomes

Measure
Incidence of patient complaints; specifically pain, vomiting, dyspepsia, and/or dysphagia.
time frame: during first 14 weeks after surgery

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Double-Blind Clinical Trial Comparing Zegerid Capsule to Famotidine in Preventing Anastomotic (Marginal) Ulcers in Post Gastric Bypass Patients
Principal investigator Roger de la Torre, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by University of Missouri-Columbia.