Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

Official Title
-----------------
A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: pantoprazole sodium enteric-coated spheroid suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 44 weeks beyond neonatal period but less than 12 months Presumptive diagnosis of GERD Weight greater than 2.5 kg but less than 15 kg Exclusion Criteria: History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption Clinically significant medical or surgical abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 11 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 sodium enteric-coated spheroid suspension<br>* pediatric suspension taken daily x 7 days<br>|
| Active Comparator: High dose<br> | Drug: pantoprazole sodium enteric-coated spheroid suspension<br>* pediatric suspension taken daily x 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Concentration (Cmax) | Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole | 1 day | 
| Time to Peak Concentration (Tmax) Profile | Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole. | 1 day | 
| Disposition Half-life | Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole. Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. | 1 day | 
| Area Under the Concentration-time Curve (AUC) | Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole. AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. | 1 day | 
| Apparent Oral Clearance (CL/F) | Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole. 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. | 1 day | 
| Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration | Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug. | 7 days | 
| Intragastric pH | Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD). | 7 days | 
| Median Intragastric pH | Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD). | 7 days | 
| Percentage of Time Intragastric pH Was >4 | Intragastric pH is a method for evaluating gastric acidity. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD). | 7 days | 
| Mean Intraesophageal pH | Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD). | 7 days | 
| Median Intraesophageal pH | Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD). | 7 days | 
| Percentage of Time That Intraesophageal pH Was <4 | Intraesophagel pH is a method for evaluating acidity of gastric refluxate. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD). | 7 days | 
| Normalized Area of Gastric Hydrogen Ion Activity Over Time | Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period. | 7 days | 
| Normalized Area of Esophageal Hydrogen Ion Activity Over Time | Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Infant