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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195208

Enrollment

Registered

2005-09-19

Start date

2005-06-30

Completion date

2005-11-30

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagitis, Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux Disease (GERD)

Brief summary

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

Interventions

DRUGPantoprazole for approximately 9 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Comparison of MAO between the two formulations.	—

Secondary

Measure	Time frame
Comparison of BAO and pH parameters between the two formulations.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026