Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133770
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2005-08-22
Brief Title:
Intravenous IV Pantoprazole in Erosive Esophagitis
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Barretts 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3001K-200042 | OTHER_GRANT | Wyeth | None |