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OpenTrials
Completed

NCT Number: NCT00557349

Ulcer Prevention Study 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.

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Key information

Conditions

Marginal Ulcers Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Postoperative Complications Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole

Drug

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.

Other names: Zegerid

Famotidine

Drug

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.

Other names: Pepcid

Primary outcomes

  1. Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.

    Time frame: during first 14 weeks after surgery

Secondary outcomes

  1. Number of Participants With Upper Endoscopy Indicated Due to Complaints

    Time frame: during first 14 weeks after surgery

    Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Nov 14, 2007
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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