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NCT01563185 · ClinicalTrials.gov registry record · Phase 4
Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis
A Phase 4 study of Juvenile Idiopathic Arthritis, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 5
- Study locations
NCT01563185: Completed Phase 4 study of Juvenile Idiopathic Arthritis, sponsored by Amgen.
NCT01563185 is a Phase 4 study of Juvenile Idiopathic Arthritis that has completed, run by Amgen. The registered enrollment target is 12 participants, below the 301-participant average among 8 other Juvenile Idiopathic Arthritis trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01563185, a Phase 4 study of Juvenile Idiopathic Arthritis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 800 mg ibuprofen/26.6 mg famotidine
Study Locations (5)
Massachusetts
- Floating Hospital for Children @ Tufts Medical Center - Boston
- UMASS Memorial Children's Medical Center - Worcester
Louisiana
- Children's Hospital - New Orleans
Pennsylvania
- Altoona Center for Clinical Research Altoona Arthritis - Duncansville
Texas
- Dell Children's Medical Center of Central Texas - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
What the finished NCT01563185 record still lists
NCT01563185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 301-participant average among 8 other Juvenile Idiopathic Arthritis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Juvenile Idiopathic Arthritis appearing as the primary indexed condition, and to 1 intervention - of which 800 mg ibuprofen/26.6 mg famotidine is the first listed.
NCT01563185 lists 5 locations in 4 states (Massachusetts, Louisiana, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01563185 about?
NCT01563185 is a clinical study titled "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...
What is the current status of trial NCT01563185?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2012-04. Estimated completion is 2015-03.
What conditions does trial NCT01563185 study?
This clinical trial studies the following conditions: Juvenile Idiopathic Arthritis.
What interventions are being tested in trial NCT01563185?
The interventions under investigation include: 800 mg ibuprofen/26.6 mg famotidine (DRUG).
Who is sponsoring clinical trial NCT01563185?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01563185 being conducted?
This trial has 5 study locations across Louisiana, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Juvenile Idiopathic Arthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01563185's enrollment target sits among peer trials
12 9th of 8 the lowest of 8 other Juvenile Idiopathic Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Juvenile Idiopathic Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis
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