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NCT01078389 · ClinicalTrials.gov registry record · Phase 2
Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 314
- Enrollment target
NCT01078389: Completed Phase 2 study, sponsored by Takeda.
NCT01078389 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 314 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (136% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078389, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 314 participants
- Enrollment target
Study Summary
This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in patients with elevated serum urate levels and gout.
Primary Outcome
The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of this single joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst). Individual erosion scores were summed to a maximum erosion score of 5 for joints in the hands and 10 for joints in the feet. Higher scores indicated mo
Interventions
- DRUG Febuxostat
- DRUG Placebo for Febuxostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01078389 record still lists
NCT01078389 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (136% higher).
The record links to 0 conditions, and to 2 interventions - of which Febuxostat is the first listed.
NCT01078389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01078389 about?
NCT01078389 is a clinical study titled "Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout". This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in patients with elevated serum urate levels and gout.
What is the current status of trial NCT01078389?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 314 participants. The study started on 2010-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01078389?
The interventions under investigation include: Febuxostat (DRUG), Placebo for Febuxostat (DRUG).
Who is sponsoring clinical trial NCT01078389?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01078389's enrollment target sits among peer trials
314 159th of 2000 higher than 1,840 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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