Esophagitis Clinical Trial
Official title:
A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis
Verified date | July 2013 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2007 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days | the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days | 7 days | Yes |
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