NCT00474019

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2007

Typical duration for phase_1

Geographic Reach
5 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

First QC Date

May 14, 2007

Last Update Submit

December 2, 2010

Conditions

Pharmacokinetics

Keywords

pediatricsneonates

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval

    Day 4 of study

Secondary Outcomes (3)

  • Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole

    Day 4 of study

  • Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG

    Days 1-4 (during treatment), Days 1-28 (post treatment)

  • 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

    Day 4

Study Arms (1)

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

Interventions

esomeprazoleDRUG

IV qd for 4 days

Also known as: Nexium
1

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Little Rock, Arkansas, United States

Location

Research Site

Hartford, Connecticut, United States

Location

Research Site

Park Ridge, Illinois, United States

Location

Research Site

Louisville, Kentucky, United States

Location

Research Site

Detroit, Michigan, United States

Location

Research Site

Southfield, Michigan, United States

Location

Research Site

New Brunswick, New Jersey, United States

Location

Research Site

Buffalo, New York, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Fort Worth, Texas, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

North Adelaide, South Australia, Australia

Location

Research Site

Brussels (jette), Belgium, Belgium

Location

Research Site

Budapest, Hungary

Location

Research Site

Gothenburg, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 27875488DERIVED

  • 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.

    PMID: 22832034DERIVED

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kurt Brown, MD

    AstraZeneca

    STUDY DIRECTOR

  • Per Lundborg, MD

    AstraZeneca

    STUDY DIRECTOR

  • Jill McGuinn

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 16, 2007

Study Start

October 1, 2007

Study Completion

October 1, 2009

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

US(11)SE(1)AU(1)BE(1)HU(1)