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Trial record 81 of 402 for:    Louisville AND Brown

Phase 1 Pharmacokinetics of Intravenous Nexium in Children

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ClinicalTrials.gov Identifier: NCT00474019
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: esomeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2007
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval [ Time Frame: Day 4 of study ]

Secondary Outcome Measures :
  1. Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole [ Time Frame: Day 4 of study ]
  2. 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) ]
  3. 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 ]


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474019


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
pediatrics
neonates

Additional relevant MeSH terms:
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Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action