Phase 1 Pharmacokinetics of Intravenous Nexium in Children

Pharmacokinetics Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474019
• Other study ID #: D9615C00021
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2007
• Last updated: December 2, 2010
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Therapeutic Goods AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeSweden: Regional Ethical Review BoardAustralia: National Health and Medical Research CouncilHungary: National Institute of PharmacySweden: Health Authority - Medical Products Agency (MPA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• esomeprazole
IV qd for 4 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Hungary,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval		Day 4 of study	No
Secondary	Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole		Day 4 of study	No
Secondary	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)	Yes
Secondary	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	No