The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation...
Date First Received: September 12, 2005
Last Updated: May 25, 2007
Verified by: Wyeth, May 2007
Clinical Trial Phase: Phase 4 | Start Date: July 2005
Overall Status: Completed
Estimated Enrollment: 65
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.”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
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 Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
