Intravenous (IV) Pantoprazole in Erosive Esophagitis

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Dr. Qiang Cai MD/PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00133770
First received: August 22, 2005
Last updated: July 29, 2013
Last verified: July 2013
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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

Resource links provided by NLM:


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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days


Enrollment: 20
Study Start Date: July 2004
Study Completion Date: March 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV pantoprazole
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
Drug: pantoprazole
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
Other Name: Protonix

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
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Qiang Cai, MD, PhD Emory University
  More Information

No publications provided

Responsible Party: Dr. Qiang Cai MD/PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00133770     History of Changes
Other Study ID Numbers: 259-2004, 3001K-200042
Study First Received: August 22, 2005
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
IV pantoprazole
Esophagitis

Additional relevant MeSH terms:
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014