• Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
• Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
• Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 52 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 Week 52. [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Serum Urate Levels at Final Visit [ Time Frame: Baseline and Final Visit (up to 52 weeks) ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Time Frame: Baseline and Final Visit (up to 52 weeks) ] [ Designated as safety issue: No ]
• Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
• Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening. [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
• Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening. [ Time Frame: Baseline and Final Visit (up to 52 weeks) ] [ Designated as safety issue: No ]
• Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52. [ Time Frame: Weeks 8 through 52 ] [ Designated as safety issue: No ]

• Reduction in gout flare incidence
• Reduction in tophus size

The purpose of this study is to evaluate the safety and efficacy of febuxostat versus allopurinol in subjects with gout.

This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.

• Drug: Febuxostat
• Drug: Allopurinol

• Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61.
• 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:

• Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
• Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Exclusion Criteria:

• Serum creatinine >1.5 mg/dL
• Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
• Pregnancy or lactation;
• Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
• Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
• A history of xanthinuria, active liver disease, or hepatic dysfunction;
• A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.