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NCT00663169 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
A Phase 2 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00663169: Completed Phase 2 study, sponsored by Novartis.
NCT00663169 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00663169, a Phase 2 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
Primary Outcome
72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.
Interventions
- DRUG dexamethasone
- BIOLOGICAL canakinumab
- OTHER placebo matching canakinumab
- OTHER placebo matching dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00663169 record still lists
NCT00663169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which dexamethasone is the first listed.
NCT00663169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00663169 about?
NCT00663169 is a clinical study titled "Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout". This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
What is the current status of trial NCT00663169?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2008-04. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00663169?
The interventions under investigation include: dexamethasone (DRUG), canakinumab (BIOLOGICAL), placebo matching canakinumab (OTHER), placebo matching dexamethasone (OTHER).
Who is sponsoring clinical trial NCT00663169?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00663169's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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