Phase 1 Pharmacokinetics of Intravenous Nexium in Children

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: esomeprazole

• Registration Number: NCT00474019
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-16
• Study Start: 2007-10
• Study Completion: 2009-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	esomeprazole	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval	Day 4 of study

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole	Day 4 of study
Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG	Days 1-4 (during treatment), Days 1-28 (post treatment)
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	Day 4

Trial Locations

Locations (1)

Research Site; 🇸🇪 Goteborg, Sweden