CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
800 mg ibuprofen/26.6 mg famotidinedrug
Likely dose
800 mg ibuprofen/26.6 mg famotidinefrom 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.

Search/NCT01563185
NCT01563185Phase 4Completed
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A Multicenter, Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis

Amgen·interventional·Posted Mar 26, 2012·Updated Dec 16, 2024

In Brief

A Phase 4 clinical trial evaluating 800 mg ibuprofen/26.6 mg famotidine for Juvenile Idiopathic Arthritis. Completed, enrolled 12 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Idiopathic Arthritis
CountriesUnited States
CollaboratorsPediatric Rheumatology Collaborative Study Group

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2012
Enrollment StartApr 1, 2012
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.3 years ago

Interventions

800 mg ibuprofen/26.6 mg famotidinedrug

Oral tablet taken three time per day