The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of \>7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond \>7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase. Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi. Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
153
Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.
Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.
Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 28 visit was summarized.
Time frame: Day 28.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.
Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 7 visit was summarized.
Time frame: Day 7.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.
Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 14 visit was summarized.
Time frame: Day 14.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.
Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 21 visit was summarized.
Time frame: Day 21.
Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.
Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.
Time frame: Baseline and Day 7.
Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.
Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.
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Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Time frame: Baseline and Day 14.
Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit
Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.
Time frame: Baseline and Day 21.
Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.
Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.
Time frame: Baseline and Day 28.
Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.
Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.
Time frame: Baseline and Any visit (Day 7, 14, 21,or 28)
Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.
24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.
Time frame: Baseline and Day 28.