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Phase 1 Pharmacokinetics of Intravenous Nexium in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00474019
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE May 14, 2007
First Posted Date  ICMJE May 16, 2007
Last Update Posted Date December 3, 2010
Study Start Date  ICMJE October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2009)
Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval [ Time Frame: Day 4 of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2007)
Evaluate PK of repeated doses of esomeprazole given as a once daily injection over 3 minutes in patients 0-17 years old, inclusive, by assessment of AUC on Day 4 of the study based on population PK modeling.
Change History Complete list of historical versions of study NCT00474019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2009)
  • Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole [ Time Frame: Day 4 of study ]
  • 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) ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Pharmacokinetics of Intravenous Nexium in Children
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE Drug: esomeprazole
IV qd for 4 days
Other Name: Nexium
Study Arms  ICMJE 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
Intervention: Drug: esomeprazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 20, 2008)
42
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Hungary,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00474019
Other Study ID Numbers  ICMJE D9615C00021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tore Lind, MD, Nexium GI Established Brands, Medical Science Director, AstraZeneca Pharmaceuticals
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kurt Brown, MD AstraZeneca
Study Director: Per Lundborg, MD AstraZeneca
Study Director: Jill McGuinn AstraZeneca
PRS Account AstraZeneca
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP