Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux; Esophagitis
Intervention: Pantoprazole for approximately 9 weeks (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
The purpose of this study is to demonstrate pharmacodynamic comparability between the
pantoprazole spheroid formulation and the marketed tablet formulation.
Clinical Details
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.
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Comparison of MAO between the two formulations.
Secondary outcome: Comparison of BAO and pH parameters between the two formulations.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Orange, California 92869, United States
San Diego, California 92103, United States
Anaheim, California 92801, United States
Los Angeles, California 90073, United States
Miami, Florida 33173, United States
Oklahoma City, Oklahoma 73104, United States
Oklahoma City, Oklahoma 73112, United States
Philadelphia, Pennsylvania 19104, United States
Philadelphia, Pennsylvania 19140, United States
Additional Information
Starting date: July 2005
Last updated: May 25, 2007
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