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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 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.

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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.

Conditions Studied

Gout

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

FieldValue
Enrollment Target 225 participants
Start Date 2006-05
Est. Completion 2007-12
Phase Phase 3

Sponsor

Savient Pharmaceuticals

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00325195

The ClinicalTrials.gov registry entry for NCT00325195 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,882-participant average among 34 other Gout trials with a reported enrollment target (97% lower). The listed sponsor is Savient Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.