Phase 1 Pharmacokinetics of Intravenous Nexium in Children

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474019

D9615C00021

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Experimental group

Description:

Based on age and/or weight dose of esomeprazole IV qd in milligrams 20,40,10,20,10, 1.0 mg/kg, 0,5 mg/kg

Treatment:

Drug: esomeprazole