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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: pantoprazole sodium enteric-coated spheroid suspension

• Registration Number: NCT00259012
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-23
• Study First Submitted QC: 2005-11-23
• Study First Posted: 2005-11-28
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Disposition First Submitted: 2009-01-21
• Results First Submitted: 2009-11-30
• Status Verified: 2010-04
• Results First Submitted QC: 2010-04-19
• Disposition First Submitted QC: 2010-04-19
• Last Update Submitted: 2010-04-19
• Results First Posted: 2010-05-07
• Disposition First Posted: 2010-05-07
• Last Update Posted: 2010-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	pantoprazole sodium enteric-coated spheroid suspension	-
High dose	pantoprazole sodium enteric-coated spheroid suspension	-

Primary Outcome Measures

Name	Time	Method
Peak Concentration (Cmax)	1 day	Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
Time to Peak Concentration (Tmax) Profile	1 day	Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
Disposition Half-life	1 day	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.
Area Under the Concentration-time Curve (AUC)	1 day	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.
Apparent Oral Clearance (CL/F)	1 day	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.
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration	7 days	Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
Intragastric pH	7 days	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).
Median Intragastric pH	7 days	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).
Percentage of Time Intragastric pH Was >4	7 days	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).
Mean Intraesophageal pH	7 days	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).
Median Intraesophageal pH	7 days	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).
Percentage of Time That Intraesophageal pH Was <4	7 days	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).
Normalized Area of Gastric Hydrogen Ion Activity Over Time	7 days	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.
Normalized Area of Esophageal Hydrogen Ion Activity Over Time	7 days	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.