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A Multicenter, Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis
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.
Details
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2012-04 |
| Completion | 2015-03 |
Conditions
- Juvenile Idiopathic Arthritis
Interventions
- 800 mg ibuprofen/26.6 mg famotidine
Primary outcomes
- Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) — Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)
Safety assessments included AE monitoring, concomitant medication review, physical examinations (including vital signs and weight), and clinical laboratory assessments, including pregnancy testing for female patients. The outcome measure data table below describes the TEAEs experienced by patients.
Countries
United States