Study Evaluating Pantoprazole in Children With GERD

Study Overview
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Brief Summary
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The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Official Title
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A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: pantoprazole for approximately 9 weeks.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endoscopically proven GERD diagnosed within 6 months before study entry. Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg Exclusion Criteria: History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis Subjects 6-11 years old unable to swallow tablets

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pantoprazole for approximately 9 weeks.|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t). | Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose | 
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose | 
| Terminal-Phase Volume of Distribution (Vz/F) | Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz). | Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose | 
| Plasma Concentrations After Multiple Doses |  | Hours 2 and 4 on Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Reflux Disease