Phase 1 Pharmacokinetics of Intravenous Nexium in Children
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: esomeprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Kurt Brown, MD, Study Director, Affiliation: AstraZeneca Per Lundborg, MD, Study Director, Affiliation: AstraZeneca Jill McGuinn, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval
Secondary outcome: Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazoleSafety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG 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
Eligibility
Minimum age: N/A.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Brussels (jette), Belgium
Research Site, Budapest, Hungary
Research Site, Goteborg, Sweden
Research Site, Little Rock, Arkansas, United States
Research Site, Hartford, Connecticut, United States
Research Site, Park Ridge, Illinois, United States
Research Site, Louisville, Kentucky, United States
Research Site, Detroit, Michigan, United States
Research Site, Southfield, Michigan, United States
Research Site, New Brunswick, New Jersey, United States
Research Site, Buffalo, New York, United States
Research Site, Cleveland, Ohio, United States
Research Site, North Adelaide, South Australia, Australia
Research Site, Fort Worth, Texas, United States
Research Site, Houston, Texas, United States
Additional Information
Starting date: October 2007
Last updated: December 2, 2010
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