Trials / Completed
CompletedNCT00663169
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | canakinumab | 10 mg/kg intravenous infusion 250 mL over 2 hours. |
| DRUG | dexamethasone | 12 mg intravenous infusion 50 mL over 30 minutes. |
| OTHER | placebo matching canakinumab | 5% glucose in water intravenous infusion. |
| OTHER | placebo matching dexamethasone | Placebo intravenous infusion. |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2008-04-22
- Last updated
- 2013-01-07
- Results posted
- 2013-01-07
Locations
4 sites across 3 countries: United States, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00663169. Inclusion in this directory is not an endorsement.