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

This study has been completed.

First Received: September 12, 2005 Last Updated: May 25, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195208

Purpose

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

Condition	Intervention	Phase
Gastroesophageal Reflux Esophagitis	Drug: Pantoprazole for approximately 9 weeks	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
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.

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Comparison of MAO between the two formulations.

Secondary Outcome Measures:

Comparison of BAO and pH parameters between the two formulations.

Estimated Enrollment:	65
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195208

Locations

United States, California

Orange, California, United States, 92869

San Diego, California, United States, 92103

Anaheim, California, United States, 92801

Los Angeles, California, United States, 90073
United States, Florida

Miami, Florida, United States, 33173
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3001B1-332
Study First Received:	September 12, 2005
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00195208 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Gastroesophageal Reflux Disease (GERD)

Additional relevant MeSH terms:

Gastrointestinal Diseases
Pantoprazole
Gastrointestinal Agents
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders

Esophagitis
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on February 08, 2010