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

Primary Purpose

Gastroesophageal Reflux, Esophagitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pantoprazole for approximately 9 weeks
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux Disease (GERD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Comparison of MAO between the two formulations.

Secondary Outcome Measures

Comparison of BAO and pH parameters between the two formulations.

Full Information

First Posted
September 12, 2005
Last Updated
February 7, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00195208
Brief Title
Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Esophagitis
Keywords
Gastroesophageal Reflux Disease (GERD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pantoprazole for approximately 9 weeks
Primary Outcome Measure Information:
Title
Comparison of MAO between the two formulations.
Secondary Outcome Measure Information:
Title
Comparison of BAO and pH parameters between the two formulations.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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