Intravenous (IV) Pantoprazole in Erosive Esophagitis
Esophagitis
About this trial
This is an interventional treatment trial for Esophagitis focused on measuring IV pantoprazole, Esophagitis
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
Sites / Locations
- Emory University School of Medicine
Arms of the Study
Arm 1
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