NCT00133770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

August 22, 2005

Last Update Submit

July 29, 2013

Conditions

Esophagitis

Keywords

IV pantoprazoleEsophagitis

Outcome Measures

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

    7 days

Study Arms (1)

IV pantoprazole

EXPERIMENTAL

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

pantoprazoleDRUG

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
IV pantoprazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Esophagitis

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritis

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Qiang Cai, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2006

Study Completion

March 1, 2007

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(1)