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Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years
Sponsor: Pfizer
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
Full dose Pantoprazole plus matching placebo
Full healing dose of pantoprazole plus matching placebo
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