Overview

Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks. The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.
Phase:
Phase 4
Details
Lead Sponsor:
Horizon Pharma Ireland, Ltd., Dublin Ireland
Collaborator:
Pediatric Rheumatology Collaborative Study Group
Treatments:
Famotidine
Ibuprofen