Status:
COMPLETED
Intravenous (IV) Pantoprazole in Erosive Esophagitis
Lead Sponsor:
Emory University
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Esophagitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 trea...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00133770
Start Date
July 1 2004
End Date
March 1 2007
Last Update
July 31 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322