The aim of this study is to examine whether 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.

Condition	Intervention	Phase
Esophagitis	Drug: pantoprazole	Phase IV

Further Study Details: 

Primary Outcomes: the percentage of patient’s healed from severe esophagitis with IV pantoprazole at 7 days
Secondary Outcomes: more controlled studies should be carried out to precisely define the healing process of severe esophagitis
Expected Total Enrollment:  18

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. 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;
2. 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;
3. Patients or his/her legally authorized representative must be capable of understanding or giving signed and dated informed consent before the study;
4. Patients with a high probability for compliance and completion of the study.

Exclusion Criteria:

1. Patients with less than grade five esophagitis;
2. Patients with esophagitis other than reflux esophagitis, such as infectious esophagitis and esophageal cancer;
3. Patients 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;
4. 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;
5. 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;
6. Patient with any malignancy (except skin cancer) which required therapy within the last 6 months;
7. Patients with history of allergy to any PPI including pantoprazole;
8. Patients with known human immunodeficiency virus infection;
9. Patients with organ transplantation;
10. Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator;
11. Patient with prior administration of any PPI (within 72 hours) or histamine-2 receptor antagonist (within previous 24 hours) of study enrollment.

Please refer to this study by ClinicalTrials.gov identifier  NCT00133770

Qiang Cai, MD, PhD      404-778-4857    qcai@emory.edu
Yoosun Han, MD      404-778-3640    yhan2@emory.edu

Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States; Recruiting

Study chairs or principal investigators

Qiang Cai, MD, PhD,  Principal Investigator,  Emory University   

Study ID Numbers:  259-2004; 3001K-200042
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133770
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30