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NCT01112982 · ClinicalTrials.gov registry record · Phase 4
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
A Phase 4 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
NCT01112982: Completed Phase 4 study, sponsored by University of South Florida.
NCT01112982 is a Phase 4 study that has completed, run by University of South Florida. The registered enrollment target is 74 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01112982, a Phase 4 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
Study Summary
The purpose of this study is to show that patients with gout suffer from chronic inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty attacks. Secondary end-points of this study will include analyzing the effects of uric acid-lowering therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients, checking for the presence of inflammatory markers to see if there is any correlation with the proposed chronic inflammation, and evaluating for other characteristic findings of gout on MRI.
Primary Outcome
The primary aim of this study will be to determine the percentage of patients with known gout who have evidence of chronic ongoing synovial-based inflammatory disease, i.e. synovial pannus, in their "index joint", and determine if there is a correlation of the prevalence and severity of synovial pannus in the "index joint" with the patients' serum urate levels on the day of their MRI.
Interventions
- DRUG Colchicine
- OTHER Magnetic Resonance Imaging
- DRUG Febuxostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01112982 record still lists
NCT01112982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Colchicine is the first listed.
NCT01112982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01112982 about?
NCT01112982 is a clinical study titled "An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.". The purpose of this study is to show that patients with gout suffer from chronic inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty attacks. Secondary end-points of this study will include analyzing the effects of uric acid-lowering therapy (specifically with t...
What is the current status of trial NCT01112982?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2010-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01112982?
The interventions under investigation include: Colchicine (DRUG), Magnetic Resonance Imaging (OTHER), Febuxostat (DRUG).
Who is sponsoring clinical trial NCT01112982?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01112982's enrollment target sits among peer trials
74 1027th of 2000 higher than 968 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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