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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Full healing dose of pantoprazole plus matching placebo
Half healing dose of pantoprazole plus matching placebo
Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures
Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24.
Time frame: Week 24
Number of Participants With Change From Baseline in Physical Examinations and Vital Signs
Safety and tolerability will be assessed by physical examinations, blood pressure, and pulse rate.
Time frame: Baseline up to 36 weeks
Incidence of Adverse Events (AEs)
Time frame: Baseline up to 36 weeks
Number of Participants With Change From Baseline in Laboratory Tests Results
Safety and tolerability will be assessed by clinical laboratory measurements
Time frame: Baseline up to 36 weeks
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