Study Evaluating Pantoprazole in Children With GERD

Gastroesophageal Reflux Clinical Trial

Official title:

A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141817
• Other study ID #: 3001B3-334
• Secondary ID: B1791059
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: November 23, 2011
• Start date: August 2005
• Est. completion date: November 2007

Study information

• Verified date: November 2011
• 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 PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• pantoprazole for approximately 9 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	No
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	No
Primary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	No
Primary	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. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	No
Primary	Terminal-Phase Volume of Distribution (Vz/F)	Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (?z).	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose	No
Primary	Plasma Concentrations After Multiple Doses		Hours 2 and 4 on Day 7	No