Intravenous (IV) Pantoprazole in Erosive Esophagitis - Full Text View

Sponsor:	Emory University
Collaborator:	Wyeth
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00133770

Purpose

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.

Condition	Intervention	Phase
Esophagitis	Drug: pantoprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis

Resource links provided by NLM:

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

more controlled studies should be carried out to precisely define the healing process of severe esophagitis

Estimated Enrollment:	18
Study Start Date:	July 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133770

Contacts

Contact: Qiang Cai, MD, PhD

404-778-4857

qcai@emory.edu

Locations

United States, Georgia
Emory University School of Medicine	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Qiang Cai, MD, PhD 404-778-4857 qcai@emory.edu
Principal Investigator: Qiang Cai, MD, PhD
Sub-Investigator: Mahmoud Barrie, MD
Sub-Investigator: Marc D Rosenberg, MD
Sub-Investigator: Henry C Olejeme, MD

Sponsors and Collaborators

Emory University

Wyeth

Investigators

Principal Investigator:

Qiang Cai, MD, PhD

Emory University

More Information

No publications provided

Study ID Numbers:	259-2004, 3001K-200042
Study First Received:	August 22, 2005
Last Updated:	December 5, 2006
ClinicalTrials.gov Identifier:	NCT00133770 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

IV pantoprazole
Esophagitis

Additional relevant MeSH terms:

Esophagitis
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Pantoprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Esophageal Diseases
Gastroenteritis
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010