Intravenous (IV) Pantoprazole in Erosive Esophagitis

• ClinicalTrials.gov Identifier: NCT00133770
• Recruitment Status: Completed
• First Posted: August 24, 2005
• Last Update Posted: July 31, 2013
• Sponsor: Emory University
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Dr. Qiang Cai MD/PhD, Emory University

Tracking Information

• First Submitted Date: August 22, 2005
• First Posted Date: August 24, 2005
• Last Update Posted Date: July 31, 2013
• Study Start Date: July 2004
• Actual Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2013)

the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days [ Time Frame: 7 days ]

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

• Original Primary Outcome Measures (submitted: August 22, 2005): the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: August 22, 2005): more controlled studies should be carried out to precisely define the healing process of severe esophagitis
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Esophagitis

Intervention

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

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

Intervention: Drug: pantoprazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2013): 20
• Original Enrollment (submitted: August 22, 2005): 18
• Actual Study Completion Date: March 2007
• Actual Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00133770
• Other Study ID Numbers: 259-2004; 3001K-200042 ( Other Grant/Funding Number: Wyeth )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Qiang Cai MD/PhD, Emory University
• Study Sponsor: Emory University
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Principal Investigator: Qiang Cai, MD, PhD; Emory University

• PRS Account: Emory University
• Verification Date: July 2013