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

Phase 3CompletedNCT00195208

Wyeth is now a wholly owned subsidiary of Pfizer97 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Esophagitis

Interventions

Pantoprazole for approximately 9 weeksDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (9)

Unnamed facility

Anaheim, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Orange, California, United States

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Comparison of MAO between the two formulations.

Secondary Outcomes

Comparison of BAO and pH parameters between the two formulations.

Data from ClinicalTrials.gov

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