Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.

Summary

The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

Timeline

Start

2003-02

Primary completion

2004-04

Completion

2004-04

Outcome

Met primary endpoint

registry Febuxostat 80 mg QD vs Placebo QD; p <0.001; Cochran-Mantel-Haenszel NCT00174915 ↗

paper higher percentages of subjects treated with febuxostat 80 mg (48%), 120 mg (65%), and 240 mg (69%) attained the primary end point PMID 18975369 ↗

Publications

• Results Schumacher HR Jr, Becker MA, Wortmann RL, Macdonald PA, Hunt B, Streit J, Lademacher C, Joseph-Ridge N. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008 Nov 15;59(11):1540-8. doi: 10.1002/art.24209.
• Results Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032.
• Results Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.
• Results Chohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.

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
Subject	Febuxostat	Small molecule	240 mg	Oral

Indications