• Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
• Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 28 weeks). ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Serum Urate Levels at Week 28. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Serum Urate Levels at Final Visit [ Time Frame: Baseline and Final Visit (up to 28 weeks) ] [ Designated as safety issue: No ]
• Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
• Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Final Visit (up to 28 weeks) ] [ Designated as safety issue: No ]
• Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
• Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit [ Time Frame: Final Visit (up to 28 weeks) ] [ Designated as safety issue: No ]
• Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period. [ Time Frame: Weeks 8 through 28 ] [ Designated as safety issue: No ]

• 1) The proportion of subjects whose serum rate levels are <6.0 mg/dL;
• 2) The percent reduction in serum urate levels;
• 3) The percent reduction in primary tophus size, as determined by physical measurement in the subset of subjects with palpable tophi at the Screening Visit;
• 4) The reduction in the total number of tophi in the subset of subjects with palpable tophi at the Screening Visit; and
• 5) The proportion of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the Double-Blind Treatment Period.

A Study comparing febuxostat, allopurinol and placebo in subjects with gout.

A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.

Subjects will receive treatment for 28 weeks.

• Drug: Febuxostat
• Drug: Allopurinol
• Drug: Placebo

• 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.
• 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.

Inclusion Criteria:

• Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
• Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

• History of xanthinuria
• Intolerance to allopurinol
• Presence of renal calculi,
• Alcohol intake of ≥ 14 drinks/week
• Clinically significant medical condition