Ulcer Prevention Study in Post Gastric Bypass Patients

NCT00557349 | Completed Phase 4 Results

• 1 other identifier: 1058337
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Marginal Ulcers

Keywords

gastric bypass surgery; anastomosis, Roux-en-Y; Complication, Postoperative

Outcome Measures

Primary Outcomes (1)

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

  during first 14 weeks after surgery

Secondary Outcomes (1)

• Number of Participants With Upper Endoscopy Indicated Due to Complaints

  during first 14 weeks after surgery

Study Arms (2)

Omeprazole

ACTIVE COMPARATOR

40 mg Omeprazole daily

Drug: Omeprazole

Famotidine

ACTIVE COMPARATOR

40 mg Famotidine daily

Drug: Famotidine

Interventions

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.

Also known as: Zegerid

Omeprazole

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.

Also known as: Pepcid

Famotidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Peptic Ulcer; Postoperative Complications

Interventions

Omeprazole; omeprazole, sodium bicarbonate drug combination; Famotidine

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Results Point of Contact

• Title: Archana Ramaswamy, MD
• Organization: University of Missouri

ramaswamya@health.missouri.edu

573-884-4003

Study Officials

• Roger de la Torre, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: March 1, 2008
• Last Updated: January 19, 2017
• Results First Posted: January 19, 2017

Record last verified: 2016-09

Locations

US (1)