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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00325195

Public ClinicalTrials.gov record NCT00325195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00325195
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Savient Pharmaceuticals
Industry
Enrollment
225 participants

Conditions and interventions

Conditions

Interventions

Other · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2006 (Type not available)
Primary completion
Oct 2007 (Actual)
Completion
Dec 2007 (Actual)
Last update posted
Feb 28, 2011

2006 – 2007

United States locations

U.S. sites
50
U.S. states
25
U.S. cities
48
Facility City State ZIP Site status
UAB Arthritis Clinical Intervention Program Birmingham Alabama 35294 —
University of Arizona Arthritis Center Tucson Arizona 85724 —
NEA Clinic Jonesboro Arkansas 72401 —
UCSD Rheumatology Division La Jolla California 92037-0943 —
Kaiser Permanente Medical Center, Clinical Trials Unit San Francisco California 94118 —
Pacific Arthritis Center Medical Group Santa Maria California 93454 —
E. Robert Harris Medical Corporation Whittier California 90601 —
Agilence Arthritis & Osteoporosis Medical Center Whittier California 90606 —
Arthritis Associates & Osteoporosis Center of Colorado Springs Colorado Springs Colorado 80910 —
Veterans Affairs Medical Center Washington D.C. District of Columbia 20422 —
Arthritis & Rheumatic Disease Specialties Aventura Florida 33180 —
Malcom Randall VA Medical Center Gainesville Florida 32608 —
Horizon Institute for Clinical Research Hollywood Florida 33021 —
Ocala Rheumatology Research Center Ocala Florida 34474 —
Arthritis & Osteoporosis Treatment Center, PA Orange Park Florida 32073 —
St. Petersburg Arthritis Center St. Petersburg Florida 33703 —
Idaho Arthritis & Osteoporosis Center Boise Idaho 83702 —
Institute of Arthritis Research Idaho Falls Idaho 83401 —
The University of Chicago Chicago Illinois 60637 —
Graves Gilbert Clinic Bowling Green Kentucky 42101 —
Peter A. Holt, M.D. Baltimore Maryland 21239 —
Malamet & Klein, MD, PA Hagerstown Maryland 21740 —
The Center for Rheumatology and Bone Research Wheaton Maryland 20902 —
Fallon Clinic, Inc Worcester Massachusetts 01605 —
Michigan Arthritis Research Center Brighton Michigan 48116 —
Justus J. Fiechtner, MD, PC Lansing Michigan 48910 —
Mayo Clinic Rochester Minnesota 55905 —
CentraCare Clinic Saint Cloud Minnesota 56377 —
Rheumatology Associates of North Jersey Teaneck New Jersey 07666 —
Mount Sinai Medical Center New York New York 10029-6574 —
Duke University Medical Center Durham North Carolina 27302 —
Brody School of Medicine, East Carolina University Greenville North Carolina 27834 —
Physicians East, P.A. Greenville North Carolina 27834 —
Carolina Atthritis Associates Wilmington North Carolina 28401 —
New Horizons Clinical Research Cincinnati Ohio 45242 —
The Cleveland Clinic Foundation Cleveland Ohio 44195 —
The Ohio State University Columbus Ohio 43210 —
STAT Research, Inc. Dayton Ohio 45402 —
David R. Mandel, MD, Inc. Mayfield Village Ohio 44143 —
Health Research of Oklahoma Oklahoma City Oklahoma 73139 —
Portland Medical Associates Portland Oregon 97224 —
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 —
Mid Atlantic Research Assoc. Philadelphia Pennsylvania 19154 —
Rheumatology Associates Charleston South Carolina 29407 —
Piedmont Arthritis, PA Greenville South Carolina 29601 —
AAMR Research Clinic Amarillo Texas 79106 —
Arthritis & Osteoporosis Center of South Texas San Antonio Texas 78232 —
Arthritis & Osteoporosis Clinic Research Center of Central Texas Waco Texas 76708 —
Arthritis Northwest, PLLC Spokane Washington 99204 —
Rheumatic Disease Center Glendale Wisconsin 53217 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00325195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 28, 2011 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00325195 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →