At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 46 enrolled
Drug / intervention
VIMOVO 250/20 +2 moredrug
Likely dose
VIMOVO 250/20 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating VIMOVO 250/20, VIMOVO 375/20, and 1 other intervention for Juvenile Idiopathic Arthritis (JIA). Completed, enrolled 46 participants across 17 sites.
Detailed Summary
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Idiopathic Arthritis (JIA)
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartApr 2012
Primary CompletionFeb 2015
TodayJul 2026
First PostedMar 5, 2012
Enrollment StartApr 1, 2012
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.3 years ago
Interventions
VIMOVO 250/20drug
250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 375/20drug
375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 500/20drug
500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months