Esophagitis Clinical Trial
Official title:
A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis
The aim of this study is to examine whether pantoprazole (Protonix) given through continuous intravenous infusion for 72 hours is superior to Protonix given through once a day IV injection in the treatment of erosive esophagitis.
Gastroesophageal reflux disease (GERD) is a very common disease that affects 20-50% of
adults in Western Countries. The disease can be divided into three clinical categories:
nonerosive reflux disease (NERD), erosive reflux disease (ERD), and Barrett's esophagus.
Intravenous (IV) infusion produces a faster and steadier acid suppression than an oral
regimen. Furthermore, some patients with severe erosive esophagitis cannot take pills by
mouth and will benefit from an IV formulation. Recently, we observed healing of severe
erosive esophagitis with continuous IV pantoprazole in several patients in 3 days. The
safety of IV pantoprazole has been demonstrated in patients with GERD, with
Zollinger-Ellison syndrome, or bleeding ulcer. This study is to define the safety and
efficacy of continuous IV pantoprazole in the treatment of severe erosive esophagitis.
Comparison: The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72
hours in the treatment of severe erosive esophagitis.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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