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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Esophagitis; Gastroesophageal Reflux

Treatments: Drug: Pantoprazole for approximately 9 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195208

3001B1-332

Details and patient eligibility

About

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

Enrollment: 97 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)