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

February 7, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
      • Los Angeles, California, United States, 90073
      • Orange, California, United States, 92869
      • San Diego, California, United States, 92103
    • Florida
      • Miami, Florida, United States, 33173
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Comparison of MAO between the two formulations.

Secondary Outcome Measures

Outcome Measure
Comparison of BAO and pH parameters between the two formulations.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3001B1-332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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