drugset / Trial / NCT00174915
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
RandomizedParallel-groupTriple-blindTreatment
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
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 |