Lansoprazole Preventing Gastroduodenal Stress Ulcerations

NCT00220909 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-01-11

No results posted yet for this study

Summary

The primary objective of this study is to determine whether lansoprazole, administered intravenously, can protect patients undergoing cardiac surgery from the development of and/or progression of previously undetected acid/peptic disorders (erosive esophagitis, gastric ulcer, duodenal ulcer, diffuse gastritis, duodenitis) as measured by the Lanza score and LA classification for esophageal injury.

The secondary objectives of this study are:

1. To determine if intravenous lansoprazole protects against the development of clinically important gastrointestinal bleeding in this population (overt bleeding or requiring blood transfusion).
2. To determine if intravenous lansoprazole maintains the intragastric pH above that for placebo throughout the study period.

Conditions

  • Patients Undergoing Elective Coronary Artery Bypass Graft

Interventions

DRUG

Lansoprazole

Sponsors & Collaborators

  • Temple University

    lead OTHER

Principal Investigators

  • Robert S Fisher, MD · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Completion
2006-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00220909 on ClinicalTrials.gov