Study Evaluating Pantoprazole in Children With GERD

November 23, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Orange, California, United States, 92868
      • San Diego, California, United States, 92103
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32610
      • Miami, Florida, United States, 33101
      • Pensacola, Florida, United States, 32504
    • Illinois
      • Park Ridge, Illinois, United States, 60068
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02115
      • Brockton, Massachusetts, United States, 02302
    • Michigan
      • Detroit, Michigan, United States, 48201
      • Flint, Michigan, United States, 48503
    • Mississippi
      • Jackson, Mississippi, United States, 39216
    • Missouri
      • Kansas City, Missouri, United States, 64108
    • New York
      • New York, New York, United States, 10032
    • Ohio
      • Cincinnati, Ohio, United States, 45229
    • Tennessee
      • Memphis, Tennessee, United States, 38105
    • Texas
      • Temple, Texas, United States, 76508
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
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)]
Time Frame: 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).
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time Frame: 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 - ∞).
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Plasma Decay Half-Life (t1/2)
Time Frame: 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.
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Apparent Oral Clearance (CL/F)
Time Frame: 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.
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Terminal-Phase Volume of Distribution (Vz/F)
Time Frame: 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).
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Plasma Concentrations After Multiple Doses
Time Frame: Hours 2 and 4 on Day 7
Hours 2 and 4 on Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

December 28, 2011

Last Update Submitted That Met QC Criteria

November 23, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3001B3-334
  • B1791059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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