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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01563185
The ClinicalTrials.gov registry entry for NCT01563185 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 301-participant average among 8 other Juvenile Idiopathic Arthritis trials with a reported enrollment target (96% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.