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NCT00829829 · ClinicalTrials.gov registry record · Phase 3
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
NCT00829829: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT00829829 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 241 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00829829, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
Study Summary
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
Primary Outcome
A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, onl
Interventions
- OTHER Placebo
- DRUG Rilonacept 80 mg
- DRUG Rilonacept 160 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00829829 record still lists
NCT00829829 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00829829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00829829 about?
NCT00829829 is a clinical study titled "PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1". The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied ...
What is the current status of trial NCT00829829?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2009-02. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00829829?
The interventions under investigation include: Placebo (OTHER), Rilonacept 80 mg (DRUG), Rilonacept 160 mg (DRUG).
Who is sponsoring clinical trial NCT00829829?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00829829's enrollment target sits among peer trials
241 1272nd of 2000 higher than 728 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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