Intravenous (IV) Pantoprazole in Erosive Esophagitis
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis|
- the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days
- more controlled studies should be carried out to precisely define the healing process of severe esophagitis
|Study Start Date:||July 2004|
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.
|Contact: Qiang Cai, MD, PhDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University School of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Qiang Cai, MD, PhD 404-778-4857 email@example.com|
|Principal Investigator: Qiang Cai, MD, PhD|
|Sub-Investigator: Mahmoud Barrie, MD|
|Sub-Investigator: Marc D Rosenberg, MD|
|Sub-Investigator: Henry C Olejeme, MD|
|Principal Investigator:||Qiang Cai, MD, PhD||Emory University|