Erosive Esophagitis Healing Maintenance Therapy with Protonix – Phase II

Study of Oral Pantoprazole in Pediatric Participants who Require Maintenance Therapy for Healed Erosive Esophagitis

Protocol Description

This multi-center study will explore how a medication called Protonix (pantoprazole) works in treating sores in the esophagus caused by erosive esophagitis in pediatric cases. Researchers aim to learn the effects and side effects of the drug to help determine the best dose for treating erosive esophagitis in children.

Study Level: Phase II

Eligibility Criteria

This study is open children, adolescents and teens who have erosive esophagitis.
Boys and Girls: Ages 1 through 17 years


During the study, participants will take Protonix at one weight-based dosage level for an 8-week period, called the healing phase. In the next 16 weeks, called the healing-maintenance phase, participants will take either the same dose or a reduced dose, based on random assignment. The study requires 6 in-person visits for screening, instructions, physical examinations, medical tests, endoscopies, and other procedures that will be conducted at specific intervals. Additionally, there will be 5 telephone check-in calls for a total of 11 scheduled interactions.
Visits: 11
Duration: About 40 weeks

Status: Open to Enrollment

Source(s) of Support


Primary Investigator

Arvind Srinath, MD

Contact Information

For more information about the study or enrollment, please contact:
Laura Mathews, Clinical Research Coordinator
412-692-5811 or
Susan Richey, RN, Clinical Research Nurse Coordinator