Lansoprazole Preventing Gastroduodenal Stress Ulcerations
NCT00220909 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2008-01-11
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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