CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,086 enrolled
Drug / intervention
Febuxostat +2 moredrug
Likely dose
Febuxostat 80 mg or 120 mg orally once daily; Allopurinol 100 mg or 300 mg orally once dailyAI-extracted
Key inclusion· 4
  • ✓Currently receiving thiazide diuretic therapy (febuxostat arm only)
  • ✓Serum urate level <8.0 mg/dL and not on uric acid-lowering therapy (except allopurinol or febuxostat)
  • ✓Completed prior Phase 3 febuxostat study (C02-009 or C02-010)
  • ✓No serious study drug-related adverse events in previous study
Key exclusion· 2
  • ✕Intolerant of allopurinol
  • ✕Other significant medical condition that would interfere with treatment, safety, or protocol compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00175019
NCT00175019Phase 3Completed
CompareCT.gov

A Phase 3, Open-Label, Randomized, Allopurinol-Controlled Study to Assess the Long-Term Safety of Oral Febuxostat in Subjects With Gout

Takeda·interventional·Posted Sep 15, 2005·Updated Jul 27, 2010

In Brief

A Phase 3 clinical trial evaluating Febuxostat and Allopurinol for Gout. Completed, enrolled 1,086 participants.

Detailed Summary

The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJul 1, 2003
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.8 years ago

Interventions

Febuxostatdrug

Febuxostat 80 mg, tablets, orally, once daily.

Febuxostatdrug

Febuxostat 120 mg, tablets, orally, once daily.

Allopurinoldrug

Allopurinol 100 mg or 300 mg, tablets, orally, once daily.