A safety study of VIMOVO in Adolescents with Juvenile Idiopathic Arthritis (JIA)
Study identifier:D1120C00037
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, with Juvenile Idiopathic Arthritis (JIA)
Medical condition
Juvenile Idiopathic Arthritis (JIA)
Phase
Phase 4
Healthy volunteers
No
Study drug
VIMOVO
Sex
All
Estimated Enrollment
60
Study type
Interventional
Age
12 Years - 16 Years
Date
Study Start Date: 01 Apr 2012
Estimated Primary Completion Date: 01 Apr 2014
Estimated Study Completion Date: 01 Apr 2014
Study design
Allocation: N/A
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Vimovo | Drug: VIMOVO 250 mg naproxen/20 mg esomeprazole magnesium oral tablet Drug: VIMOVO 375 mg naproxen/20 mg esomeprazole magnesium oral tablet Drug: VIMOVO 500 mg naproxen/20 mg esomeprazole magnesium oral tablet |
Contacts
Investigators
Principal Investigator
Stephen J Kanes
AstraZeneca R&D Wilmington
