MedTrace Logo

Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

NCT00325195 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2011-02-28

Study results available
· View outcomes & findings →

Summary

These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies, or for whom those therapies have been unsuccessful in controlling their uric acid level.

Conditions

Interventions

OTHER

placebo

placebo by intravenous infusion every 2 weeks

BIOLOGICAL

pegloticase

8 mg pegloticase by intravenous infusion

Sponsors & Collaborators

  • Savient Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Savient Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-10-31
Completion
2007-12-31

Countries

  • United States
  • Canada
  • Mexico

Study Locations

More Related Trials

Entities

Diseases

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 NCT00325195 on ClinicalTrials.gov