drugset / Trial / NCT00080210

A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy

NCT00080210

Phase 2 Completed 40 enrolled Savient Pharmaceuticals
RandomizedSingle-groupOpen-labelTreatment

Summary

This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.

Timeline

Start
2004-03
Primary completion
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegloticase Protein / enzyme biologic 4 mg Intravenous
Subject Pegloticase Protein / enzyme biologic 8 mg Intravenous
Subject Pegloticase Protein / enzyme biologic 12 mg Intravenous

Indications