Clinical trial NCT00474019: Phase 1 Pharmacokinetics of Intravenous Nexium in Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: pediatrics
neonates
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-05-16
Enrollment: 42
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval
timeFrame: Day 4 of study
Secondary outcomes:
measure: Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole
timeFrame: Day 4 of study
measure: Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG
timeFrame: Days 1-4 (during treatment), Days 1-28 (post treatment)
measure: 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
timeFrame: Day 4
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Hartford
country: United States
facility: Research Site
state: Connecticut
city: Park Ridge
country: United States
facility: Research Site
state: Illinois
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Southfield
country: United States
facility: Research Site
state: Michigan
city: New Brunswick
country: United States
facility: Research Site
state: New Jersey
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: North Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Brussels (jette)
country: Belgium
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Kurt Brown, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Per Lundborg, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Jill McGuinn
role: STUDY_DIRECTOR
References:
citation: Earp JC, Mehrotra N, Peters KE, Fiorentino RP, Griebel D, Lee SC, Mulberg A, Rohss K, Sandstrom M, Taylor A, Tornoe CW, Wynn EL, Van der Walt JS, Garnett C. Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):272-277. doi: 10.1097/MPG.0000000000001467.
citation: Sandstrom M, Davidson G, Tolia V, Sullivan JE, Langstrom G, Lundborg P, Brown K. Phase I, multicenter, randomized, open-label study evaluating the pharmacokinetics and safety profile of repeated once-daily doses of intravenous esomeprazole in children 0 to 17 years of age. Clin Ther. 2012 Aug;34(8):1828-38. doi: 10.1016/j.clinthera.2012.06.028. Epub 2012 Jul 24.