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

NCT04821310 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Esophagitis

Interventions

DRUG

Full dose Pantoprazole plus matching placebo

Full healing dose of pantoprazole plus matching placebo

DRUG

Half Dose Pantoprazole plus matching placebo

Half healing dose of pantoprazole plus matching placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2025-12-16
Completion
2025-12-16
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Georgia
  • India
  • Puerto Rico
  • Serbia
  • Slovakia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821310 on ClinicalTrials.gov