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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259012
• Other study ID #: 3001B3-333, 3001B3-335
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2005
• Last updated: April 19, 2010
• Start date: November 2005
• Est. completion date: March 2008

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 11 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	Nycomed

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Concentration (Cmax)	Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole	1 day	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No