Phase 1 Pharmacokinetics of Intravenous Nexium in Children

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT00474019

Run by

AstraZeneca

People needed

42

Starts

2007-10-01

Expected to finish

2009-10-01

Last updated by the study team

2010-12-03

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Little Rock, Arkansas, United States
• Research Site — Hartford, Connecticut, United States
• Research Site — Park Ridge, Illinois, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Southfield, Michigan, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — Buffalo, New York, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Fort Worth, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — North Adelaide, South Australia, Australia
• Research Site — Brussels (jette), Belgium, Belgium
• Research Site — Budapest, Hungary
• Research Site — Gothenburg, Sweden

Full record on ClinicalTrials.gov

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