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

Sponsor:	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 a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.

Condition	Intervention	Phase
Pharmacokinetics	Drug: esomeprazole	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval [ Time Frame: Day 4 of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum plasma concentration, 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 ]
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 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	October 2007
Study Completion Date:	October 2009

Arms	Assigned Interventions
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	Drug: esomeprazole IV qd for 4 days Other Name: Nexium

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

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Kurt Brown, MD	AstraZeneca
Study Director:	Per Lundborg, MD	AstraZeneca
Study Director:	Jill McGuinn	AstraZeneca

More Information

No publications provided

Responsible Party:	Tore Lind, MD, Nexium GI Established Brands, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00474019 History of Changes
Other Study ID Numbers:	D9615C00021
Study First Received:	May 14, 2007
Last Updated:	December 2, 2010
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

Additional relevant MeSH terms:

Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012