At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 225 enrolled
Drug / intervention
pegloticase +1 morebiological
Likely dose
pegloticase 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating placebo and pegloticase for Gout. Completed, enrolled 225 participants across 56 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesCanada, Mexico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedMay 2006
Primary CompletionOct 2007
Study CompletionDec 2007
TodayJul 2026
First PostedMay 12, 2006
Enrollment StartMay 1, 2006
Primary CompletionOct 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.1 years ago
Interventions
placeboother
placebo by intravenous infusion every 2 weeks
pegloticasebiological
8 mg pegloticase by intravenous infusion