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A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)

NCT01544114 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-17

Study results available
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Summary

A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.

Conditions

  • Juvenile Idiopathic Arthritis (JIA)

Interventions

DRUG

VIMOVO 250/20

250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

DRUG

VIMOVO 375/20

375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

DRUG

VIMOVO 500/20

500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544114 on ClinicalTrials.gov