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Study Evaluating Pantoprazole in Children With GERD

Primary Purpose

Gastroesophageal Reflux

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

pantoprazole for approximately 9 weeks.

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastrointestinal Reflux Disease

Eligibility Criteria

1 Year - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

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).

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

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)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

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.

Terminal-Phase Volume of Distribution (Vz/F)

Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).

Plasma Concentrations After Multiple Doses

Secondary Outcome Measures

Full Information

NCT ID

NCT00141817

First Posted

August 30, 2005

Last Updated

November 23, 2011

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00141817

Brief Title

Study Evaluating Pantoprazole in Children With GERD

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux

Keywords

Gastrointestinal Reflux Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

pantoprazole for approximately 9 weeks.

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Time Frame