Intravenous (IV) Pantoprazole in Erosive Esophagitis

Completed · Phase 4

Conditions studied: Esophagitis

In brief

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.

Key facts

Study ID

NCT00133770

Run by

Emory University

People needed

20

Starts

2004-07-01

Expected to finish

2007-03-01

Last updated by the study team

2013-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Emory University School of Medicine — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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