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Phase 1 Pharmacokinetics of Intravenous Nexium in Children

NCT ID: NCT00474019

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacokinetics

Keywords

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pediatrics neonates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

esomeprazole

Intervention Type DRUG

IV qd for 4 days

Interventions

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esomeprazole

IV qd for 4 days

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Kurt Brown, MD

Role: STUDY_DIRECTOR

AstraZeneca

Per Lundborg, MD

Role: STUDY_DIRECTOR

AstraZeneca

Jill McGuinn

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Little Rock, Arkansas, United States

Site Status

Research Site

Hartford, Connecticut, United States

Site Status

Research Site

Park Ridge, Illinois, United States

Site Status

Research Site

Louisville, Kentucky, United States

Site Status

Research Site

Detroit, Michigan, United States

Site Status

Research Site

Southfield, Michigan, United States

Site Status

Research Site

New Brunswick, New Jersey, United States

Site Status

Research Site

Buffalo, New York, United States

Site Status

Research Site

Cleveland, Ohio, United States

Site Status

Research Site

Fort Worth, Texas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

North Adelaide, South Australia, Australia

Site Status

Research Site

Brussels (jette), Belgium, Belgium

Site Status

Research Site

Budapest, , Hungary

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Countries

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United States Australia Belgium Hungary Sweden

References

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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.

Reference Type DERIVED
PMID: 27875488 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22832034 (View on PubMed)

Other Identifiers

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D9615C00021

Identifier Type: -

Identifier Source: org_study_id