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.”

The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through vein)doses of a drug called Nexium (Nexium IV is also known as esomeprazole sodium) gets into the bloodstream of children aged 0-17 years old who may benefit from acid suppression therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: esomeprazole
  • IV qd for 4 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 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 Measures

• Evaluate PK of repeated doses of esomeprazole given as a once daily injection over 3 minutes in patients 0-17 years old, inclusive, by assessment of AUC on Day 4 of the study based on population PK modeling.
  • Time Frame: Day 4 of study
    Safety Issue?: No

Secondary Measures

• Maximum plasma concentration, plasma elimination half-life, total plasma clearance, steady-state volume of distribution of esomeprazole
  • Time Frame: Day 4 of study
    Safety Issue?: No
• 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)
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Kurt Brown, MD Study Director AstraZeneca  

Overall Contact: AstraZeneca Cinical Study, Information 800-236-9933 information.center@astrazeneca.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00474019

Study ID Number: D9615C00021

ClinicalTrials.gov Identifier: NCT00474019

Health Authority: United States: Food and Drug Administration