Phase 1 Pharmacokinetics of Intravenous Nexium in Children - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00474019

Purpose

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.

Condition	Intervention	Phase
Pharmacokinetics	Drug: esomeprazole	Phase I

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

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

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum plasma concentration, plasma elimination half-life, total plasma clearance, steady-state volume of distribution of esomeprazole [ Time Frame: Day 4 of study ] [ Designated as 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	42
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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	Drug: esomeprazole IV qd for 4 days

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474019

Contacts

Contact: AstraZeneca Cinical Study, Information	800-236-9933	information.center@astrazeneca.com
Contact: AstraZeneca Information Outside US	001-800-236-9933

Locations

United States, Arkansas
Research Site	Recruiting
LITTLE ROCK, Arkansas, United States
United States, Connecticut
Research Site	Not yet recruiting
HARTFORD, Connecticut, United States
United States, Illinois
Research Site	Not yet recruiting
PARK RIDGE, Illinois, United States
United States, Kentucky
Research Site	Recruiting
LOUISVILLE, Kentucky, United States
United States, Michigan
Research Site	Not yet recruiting
DETROIT, Michigan, United States
Research Site	Not yet recruiting
SOUTHFIELD, Michigan, United States
United States, New Jersey
research Site	Not yet recruiting
New Brunswick, New Jersey, United States
United States, New York
Research Site	Not yet recruiting
Buffalo, New York, United States
United States, Ohio
Research Site	Recruiting
CLEVELAND, Ohio, United States
United States, Pennsylvania
Research Site	Not yet recruiting
PHILADELPHIA, Pennsylvania, United States
United States, Texas
Research Site	Not yet recruiting
HOUSTON, Texas, United States
Research Site	Not yet recruiting
Fort Worth, Texas, United States
Australia, South Australia
Research Site	Recruiting
NORTH ADELAIDE, South Australia, Australia
Hungary
Research Site	Recruiting
BUDAPEST, Hungary
Sweden
Research Site	Recruiting
GOTEBORG, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Kurt Brown, MD	AstraZeneca
Study Director:	Per Lundborg, MD	AstraZeneca
Study Director:	John Slowick	AstraZeneca

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Tore Lind, MD, Nexium GI Established Brands, Medical Science Director )
Study ID Numbers:	D9615C00021
Study First Received:	May 14, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00474019
Health Authority:	United States: Food and Drug Administration; Australia: Therapeutic Goods Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Sweden: Regional Ethical Review Board; Australia: National Health and Medical Research Council; Hungary: National Institute of Pharmacy; Sweden: Health Authority - Medical Products Agency (MPA)

Keywords provided by AstraZeneca:

pediatrics
neonates

Study placed in the following topic categories:

Omeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009