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Completed

NCT Number: NCT00141817

Study Evaluating Pantoprazole in Children With 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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

1 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pantoprazole for approximately 9 weeks.

Drug

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

  3. 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).

  4. 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 - ∞).

  5. 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.

  6. 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.

  7. 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).

  8. Plasma Concentrations After Multiple Doses

    Time frame: Hours 2 and 4 on Day 7

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 1, 2005
Registry last updated
Dec 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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