Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis

Phase 3

Completed

• Conditions: Gastroesophageal Reflux; Esophagitis

• Registration Number: NCT00195208
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Comparison of MAO between the two formulations.

Secondary Outcome Measures

Name	Time	Method
Comparison of BAO and pH parameters between the two formulations.