The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,072
Febuxostat 80 mg, orally, once daily for up to 28 weeks.
Febuxostat 120 mg, orally, once daily for up to 28 weeks.
Febuxostat 240 mg, orally, once daily for up to 28 weeks.
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).
Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.
Time frame: Last 3 visits (any last 3 visits up to week 28)
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28
Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Week 28 visit was summarized.
Time frame: Week 28
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
The percentage of subjects whose serum urate was \<6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected and may have differed by subject.
Time frame: Final Visit (up to 28 weeks).
Percent Change From Baseline in Serum Urate Levels at Week 28.
Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as \[(Week 28 - baseline levels)/baseline\]\*100 and summarized.
Time frame: Baseline and Week 28
Percent Change From Baseline in Serum Urate Levels at Final Visit
The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as \[(Final visit - baseline levels)/baseline\]\*100. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.
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Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine \>1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
Placebo, orally, once daily for up to 28 weeks.
Time frame: Baseline and Final Visit (up to 28 weeks)
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.
The percent change from baseline in primary tophus size as determined by physical measurement was calculated as \[(Week 28 - baseline sizes)/baseline\]\*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.
Time frame: Baseline and Week 28
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.
Percent change in primary tophus size was calculated as \[(Final Visit - baseline sizes)/baseline\]\*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.
Time frame: Baseline and Final Visit (up to 28 weeks)
Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.
Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0.
Time frame: Baseline and Week 28
Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit
Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.
Time frame: Final Visit (up to 28 weeks)
Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.
Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.
Time frame: Weeks 8 through 28