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CompletedNCT00133770Updated Jul 31, 2013

Intravenous (IV) Pantoprazole in Erosive Esophagitis

A Phase 4 interventional study of pantoprazole in Esophagitis, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-31.

Sponsored by Emory University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophagitis

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Keywords

  • IV pantoprazole
  • Esophagitis
03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 20 is below the median of 66 across 215 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

Interventions

  • Drugpantoprazole

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

    Also known as: Protonix

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 days

07

Study locations

1 site
  • Emory University School of Medicine
    Atlanta, Georgia 30322, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00133770
Lead sponsor
Emory University
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Responsible party
Dr. Qiang Cai MD/PhD (Professor, Emory University) — Principal investigator
First posted
Aug 24, 2005
Start date
Jul 2004
Primary completion
Jul 2006
Completion
Mar 2007
Last update
Jul 31, 2013

Study contacts

Qiang Cai, MD, PhD
principal investigator · Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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