Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Study Overview
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Brief Summary
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The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.

Official Title
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A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: pantoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients Presumed diagnosis of GERD Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks Exclusion Criteria: cardiovascular instability clinically significant laboratory abnormalities use of warfarin, carbamazepine, phenytoin, or rifampin

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose<br> | Drug: pantoprazole<br> <br> |
| Active Comparator: High dose<br> | Drug: pantoprazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variance of Oral Bioavailability | Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was >1.2. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve (AUC) | AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling. | Baseline to 24 hours post dose on Day 1 | 
| 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. | 1 day | 
| Half Life | Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety