NCT01563185

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 30 JIA patients who meet all eligibility criteria and who are expected to require daily administration of an NSAID for up to 24 weeks will be enrolled. A subset of approximately 6 patients will participate in a single dose PK study at Day 0 with an abbreviated PK profile performed at Week 4 if possible. Multiple dose PK sampling will occur in all enrolled patients. Study with completed results acquired from Horizon in 2024

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	800 mg ibuprofen/26.6 mg famotidine	Oral tablet taken three time per day

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-03-26
• Last updated: 2024-12-16
• Results posted: 2015-12-23

Locations

5 sites across 1 country: United States