Study Evaluating Pantoprazole in Children With GERD

Phase 3

Completed

• Conditions: Gastroesophageal Reflux

• Registration Number: NCT00141817
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2011-11
• Results First Submitted: 2011-11-23
• Results First Submitted QC: 2011-11-23
• Last Update Submitted: 2011-11-23
• Results First Posted: 2011-12-28
• Last Update Posted: 2011-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)]	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	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 - ∞).
Plasma Decay Half-Life (t1/2)	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	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.
Terminal-Phase Volume of Distribution (Vz/F)	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).
Plasma Concentrations After Multiple Doses	Hours 2 and 4 on Day 7