Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010

Phase 3 Completed 1086 enrolled Takeda

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2003-07
Primary completion: 2007-02
Completion: 2007-02

Publications

Results Becker MA, Schumacher HR, MacDonald PA, Lloyd E, Lademacher C. Clinical efficacy and safety of successful longterm urate lowering with febuxostat or allopurinol in subjects with gout. J Rheumatol. 2009 Jun;36(6):1273-82. doi: 10.3899/jrheum.080814. Epub 2009 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Allopurinol	Small molecule	100 mg	Oral
Comparator	Allopurinol	Small molecule	300 mg	Oral
Subject	Febuxostat	Small molecule	80 mg	Oral
Subject	Febuxostat	Small molecule	120 mg	Oral

Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010

Summary

Timeline

Publications

Drugs

Indications