drugset / Trial / NCT04821310

Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

NCT04821310 ↗

Phase 2 Terminated 43 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

Timeline

Start
2022-01-13
Primary completion
2025-12-16
Completion
2025-12-16

Outcome

Outcome not reported

Stopped (Business): “Pfizer has made an internal business decision to terminate the B1791094 study. This decision was not due to safety concerns or requests from any regulatory authorities.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pantoprazole Other / unclassified — Oral

Indications