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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT01563185

Public ClinicalTrials.gov record NCT01563185. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 2:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01563185
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Amgen
Industry
Enrollment
12 participants

Conditions and interventions

Eligibility (public fields only)

Age range
10 Years to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2012
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015
Last update posted
Dec 15, 2024

2012 – 2015

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
Children's Hospital New Orleans Louisiana 70118
Floating Hospital for Children @ Tufts Medical Center Boston Massachusetts 02111
UMASS Memorial Children's Medical Center Worcester Massachusetts 01655
Altoona Center for Clinical Research Altoona Arthritis Duncansville Pennsylvania 16635
Dell Children's Medical Center of Central Texas Austin Texas 78723

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01563185, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 15, 2024 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01563185 live on ClinicalTrials.gov.

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