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Completed

NCT Number: NCT00474019

Phase 1 Pharmacokinetics of Intravenous Nexium in Children

The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.

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Key information

Conditions

Pharmacokinetics

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, North Adelaide, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • parent/guardian must sign consent form and the child will be asked to sign and Assent Form if he/she is old enough and is able to sign
  • verbal assent will be acceptable if the child is old enough to understand, but unable to write
  • female and/or male hospitalized patients aged 0-17 years old who should be considered for treatment with acid suppressive therapy.

Exclusion criteria

  • female patients that are pregnant, or plan to become pregnant during the study period or is breast-feeding a child
  • patients with a history of multiple drug allergies
  • any illness, medical history, abnormal laboratory values, abnormal physical examination findings or abnormal vitals signs that could put the patient at risk when participating in the study

Treatment and study plan

Esomeprazole

Drug

IV qd for 4 days

Other names: Nexium

Primary outcomes

  1. Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval

    Time frame: Day 4 of study

Secondary outcomes

  1. Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole

    Time frame: Day 4 of study

  2. Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG

    Time frame: Days 1-4 (during treatment), Days 1-28 (post treatment)

  3. Evaluate main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) by assessment of max plasma conc, total area under the plasma concentration vs time curve within a dosing interval, clearance scaled by fraction metabolised

    Time frame: Day 4

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Open-label, Multi-National Study to Evaluate the Pharmacokinetics of Repeated Once-Daily Intravenous Doses of Esomeprazole in Paediatric Patients 0 to 17 Years Old, Inclusive.

Important dates

Study start
2007
Study completion
2009
First posted
May 16, 2007
Registry last updated
Dec 3, 2010

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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