- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00133770
Intravenous (IV) Pantoprazole in Erosive Esophagitis
A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis
Study Overview
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 (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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School Of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days
Time Frame: 7 days
|
the percentage of patients healed from severe esophagitis with IV pantoprazole at 7 days
|
7 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 259-2004
- 3001K-200042 (OTHER_GRANT: Wyeth)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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