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Intravenous (IV) Pantoprazole in Erosive Esophagitis

Primary Purpose

Esophagitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pantoprazole
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagitis focused on measuring IV pantoprazole, Esophagitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must be men or non-pregnant women (a documented negative pregnancy test at enrollment for females of child bearing age) at least 18 years of age Patients who present with a severe erosive esophagitis - confirmed by endoscopy (a baseline endoscopy within 24 hours of study enrollment) to be grade five or six, with or without stricture and/or ulcer Patients or their legally authorized representatives must be capable of understanding or giving signed and dated informed consent before the study Patients with a high probability for compliance and completion of the study Exclusion Criteria: Patients with less than grade five esophagitis Patients with esophagitis other than reflux esophagitis, such as infectious esophagitis and esophageal cancer Patients who present with gastrointestinal bleeding, hematocrit decrease greater than 6 units or require more than 2 units transfusion at the presentation or during the time of the study Patients with severe comorbidities, such as liver diseases with asparate transaminase (AST) or alanine transaminase (ALT) greater than 3 times upper limit normal (ULN); alkaline phosphatase greater than 5 times the ULN; total bilirubin greater than 3.0 mg/dl; kidney diseases with serum creatinine greater than 2.0 mg/dl in men or 1.6 mg/dl in women; heart diseases; lung diseases; sepsis; and airway intubation. Patients with history of glaucoma in either eye; history of any intraocular eye surgery within preceding 3 months; history of, or presence of, signs of optic nerve swelling; history of acute change in vision; or vision loss in either eye. Patients with any malignancy (except skin cancer) which required therapy within the last 6 months Patients with history of allergy to any proton-pump inhibitor (PPI) including pantoprazole Patients with known human immunodeficiency virus infection Patients with organ transplantation Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator Patients with prior administration of any PPI (within 72 hours) or histamine-2 receptor antagonist (within previous 24 hours) of study enrollment

Sites / Locations

  • Emory University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV pantoprazole

Arm Description

The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis

Outcomes

Primary Outcome Measures

the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days
the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days

Secondary Outcome Measures

Full Information

First Posted
August 22, 2005
Last Updated
July 29, 2013
Sponsor
Emory University
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00133770
Brief Title
Intravenous (IV) Pantoprazole in Erosive Esophagitis
Official Title
A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis
Keywords
IV pantoprazole, Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV pantoprazole
Arm Type
Experimental
Arm Description
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
Intervention Type
Drug
Intervention Name(s)
pantoprazole
Other Intervention Name(s)
Protonix
Intervention Description
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
Primary Outcome Measure Information:
Title
the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days
Description
the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be men or non-pregnant women (a documented negative pregnancy test at enrollment for females of child bearing age) at least 18 years of age Patients who present with a severe erosive esophagitis - confirmed by endoscopy (a baseline endoscopy within 24 hours of study enrollment) to be grade five or six, with or without stricture and/or ulcer Patients or their legally authorized representatives must be capable of understanding or giving signed and dated informed consent before the study Patients with a high probability for compliance and completion of the study Exclusion Criteria: Patients with less than grade five esophagitis Patients with esophagitis other than reflux esophagitis, such as infectious esophagitis and esophageal cancer Patients who present with gastrointestinal bleeding, hematocrit decrease greater than 6 units or require more than 2 units transfusion at the presentation or during the time of the study Patients with severe comorbidities, such as liver diseases with asparate transaminase (AST) or alanine transaminase (ALT) greater than 3 times upper limit normal (ULN); alkaline phosphatase greater than 5 times the ULN; total bilirubin greater than 3.0 mg/dl; kidney diseases with serum creatinine greater than 2.0 mg/dl in men or 1.6 mg/dl in women; heart diseases; lung diseases; sepsis; and airway intubation. Patients with history of glaucoma in either eye; history of any intraocular eye surgery within preceding 3 months; history of, or presence of, signs of optic nerve swelling; history of acute change in vision; or vision loss in either eye. Patients with any malignancy (except skin cancer) which required therapy within the last 6 months Patients with history of allergy to any proton-pump inhibitor (PPI) including pantoprazole Patients with known human immunodeficiency virus infection Patients with organ transplantation Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator Patients with prior administration of any PPI (within 72 hours) or histamine-2 receptor antagonist (within previous 24 hours) of study enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Cai, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Intravenous (IV) Pantoprazole in Erosive Esophagitis

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