Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis
The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation...
Brief Summary
Official Title: “A Randomized, 2-Period, Crossover, Pharmacodynamic Comparability Study Comparing A Pantoprazole Spheroid Formulation to the Currently Marketed Tablet Formulation in Subjects With GERD and a History of Erosive Esophagitis.”
The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Pantoprazole for approximately 9 weeks
Outcome Measures for this Clinical Trial
Primary Measures
- Comparison of MAO between the two formulations.
Secondary Measures
- Comparison of BAO and pH parameters between the two formulations.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- GERD and a history of Erosive Esophagitis documented by endoscopy
- H. pylori negative
Exclusion Criteria:
- Gastrointestinal conditions such as esophageal stricture, esophageal varices, previous vagotomy
- Achlorhydria
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00195208
Study ID Number: 3001B1-332
ClinicalTrials.gov Identifier: NCT00195208
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00195208
