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Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

NCT00663169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-01-07

Study results available
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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

  • Arthritis, Gouty

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis investigator site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663169 on ClinicalTrials.gov