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NCT00325195 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
A Phase 3 study of Gout, sponsored by Savient Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT00325195: Completed Phase 3 study of Gout, sponsored by Savient Pharmaceuticals.
NCT00325195 is a Phase 3 study of Gout that has completed, run by Savient Pharmaceuticals. The registered enrollment target is 225 participants, below the 8,882-participant average among 34 other Gout trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00325195, a Phase 3 study of Gout, has completed, sponsored by Savient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations \< 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.
Conditions Studied
Interventions
- OTHER placebo
- BIOLOGICAL pegloticase
Study Locations (20)
Florida
- Arthritis & Rheumatic Disease Specialties - Aventura
- Malcom Randall VA Medical Center - Gainesville
- Horizon Institute for Clinical Research - Hollywood
- Ocala Rheumatology Research Center - Ocala
- Arthritis & Osteoporosis Treatment Center, PA - Orange Park
- St. Petersburg Arthritis Center - St. Petersburg
California
- UCSD Rheumatology Division - La Jolla
- Kaiser Permanente Medical Center, Clinical Trials Unit - San Francisco
- Pacific Arthritis Center Medical Group - Santa Maria
- E. Robert Harris Medical Corporation - Whittier
- Agilence Arthritis & Osteoporosis Medical Center - Whittier
Idaho
- Idaho Arthritis & Osteoporosis Center - Boise
- Institute of Arthritis Research - Idaho Falls
Alabama
- UAB Arthritis Clinical Intervention Program - Birmingham
Arizona
- University of Arizona Arthritis Center - Tucson
Arkansas
- NEA Clinic - Jonesboro
Colorado
- Arthritis Associates & Osteoporosis Center of Colorado Springs - Colorado Springs
District of Columbia
- Veterans Affairs Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2006-05 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00325195 record still lists
NCT00325195 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 8,882-participant average among 34 other Gout trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00325195 names 20 study sites across 10 states, led by Florida, California, Idaho.
Frequently Asked Questions
What is clinical trial NCT00325195 about?
NCT00325195 is a clinical study titled "Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout". 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 co...
What is the current status of trial NCT00325195?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2006-05. Estimated completion is 2007-12.
What conditions does trial NCT00325195 study?
This clinical trial studies the following conditions: Gout.
What interventions are being tested in trial NCT00325195?
The interventions under investigation include: placebo (OTHER), pegloticase (BIOLOGICAL).
Who is sponsoring clinical trial NCT00325195?
This trial is sponsored by Savient Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00325195 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gout
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00325195's enrollment target sits among peer trials
225 11th of 34 higher than 24 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Dotinurad Versus Allopurinol in Participants With Gout
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-
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
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Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
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-
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
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