Intravenous (IV) Pantoprazole in Erosive Esophagitis

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Pantoprazole

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