Phase 1 Pharmacokinetics of Intravenous Nexium in Children
Study identifier:D9615C00021
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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.
Medical condition
pharmacokinetics
Phase
Phase 1
Healthy volunteers
No
Study drug
esomeprazole
Sex
All
Actual Enrollment
42
Study type
Interventional
Age
N/A - 17 Years
Date
Study Start Date: 01 Oct 2007
Primary Completion Date: -
Study Completion Date: 01 Oct 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 |
Contacts
Investigators
Principal Investigator
Kurt Brown
AstraZeneca
