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

Gastroesophageal Reflux Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195208
• Other study ID #: 3001B1-332
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: February 7, 2013
• Start date: June 2005
• Est. completion date: November 2005

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis
• Gastroesophageal Reflux

Intervention

Drug:
• Pantoprazole for approximately 9 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of MAO between the two formulations.
Secondary	Comparison of BAO and pH parameters between the two formulations.