Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
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.
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
- Enrollment
- 225 participants
Conditions and interventions
Conditions
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
- Apr 30, 2006
- Primary completion
- Sep 30, 2007
- Completion
- Nov 30, 2007
- Last update posted
- Feb 27, 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 27, 2011 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00325195 live on ClinicalTrials.gov.