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

• ClinicalTrials.gov Identifier: NCT00195208
• Recruitment Status: Completed
• First Posted: September 19, 2005
• Last Update Posted: February 8, 2013
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 19, 2005
• Last Update Posted Date: February 8, 2013
• Study Start Date: June 2005
• Actual Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 12, 2005): Comparison of MAO between the two formulations.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 12, 2005): Comparison of BAO and pH parameters between the two formulations.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• Brief Summary: The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Gastroesophageal Reflux
• Esophagitis

• Intervention: Drug: Pantoprazole for approximately 9 weeks
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2013): 97
• Original Enrollment (submitted: September 12, 2005): 65
• Actual Study Completion Date: November 2005
• Actual Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00195208
• Other Study ID Numbers: 3001B1-332
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: February 2013