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TERMINATED
NCT04821310
PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: AN EXPLORATORY, MULTICENTER, RANDOMIZED, DOUBLE BLIND STUDY OF CLINICAL OUTCOMES, TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS

Key Details

Gender

All

Age Range

1 Year - 17 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2022-01-13

Completion Date

2025-12-16

Last Updated

2026-06-15

Healthy Volunteers

No

Conditions

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

Locations (27)

Baptist/Wolfson's Children's Hospital

Jacksonville, Florida, United States

Nemours Children's Health, Jacksonville

Jacksonville, Florida, United States

University of Rochester

Rochester, New York, United States

University of Rochester Medical Center Clinical Research Center

Rochester, New York, United States

Board of Regents of the University of Wisconsin System

Madison, Wisconsin, United States

UW Health E Terrace Dr Medical Center

Madison, Wisconsin, United States

University Hospital and UW Health Clinics

Madison, Wisconsin, United States

UW Health 2275 Deming Way Clinic

Middleton, Wisconsin, United States

University clinical center of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina

JSC Georgian Clinics

Tbilisi, Georgia

LTD Imedi Clinic

Tbilisi, Georgia

Georgian-American Family Medicine Clinic

Tbilisi, Georgia

SR Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, India

Medical college and Hospital

Kolkata, West Bengal, India

Hospital HIMA San Pablo Caguas

Caguas, Puerto Rico

Chiara Biaggi de Casenave, MD

Guaynabo, Puerto Rico

University Children's Hospital

Belgrade, Serbia

University Clinical Center of Kragujevac

Kragujevac, Serbia

Univerzitna nemocnica Martin, Klinika deti a dorastu

Martin, Slovakia

KM Management, spol. s r.o.,

Nitra, Slovakia

MDX Klinik Arastirma Egitim ve Danismanlik Ltd

Istanbul, Turkey (Türkiye)

Izmir Saglik Bilimleri University Tepecik Training And Research Hospital

Izmir, Turkey (Türkiye)

T.C. Saglik Bakanligi - Izmir Sehir Hastanesi

Izmir, Turkey (Türkiye)

Evelina London Children's Hospital

London, United Kingdom

Guys & St Thomas Nhs Foundation

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Great Ormond Street Hospital For Children NHS Foundation Trust

London, United Kingdom