Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 24 investigative sites from 31 January 2001 to 9 July 2001

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups. All other subjects also initiated prophylactic medications.

Reporting Groups

	Description
Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg QD	Febuxostat 120 mg, orally, once daily.
Placebo QD	Placebo, orally, once daily

Participant Flow:   Overall Study

	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
STARTED	37	40	38	38
COMPLETED	36	37	36	36
NOT COMPLETED	1	3	2	2
Adverse Event	1	2	2	1
Gout Flare	0	0	0	1
Not Specified	0	1	0	0

Reporting Groups

	Description
Febuxostat 40 mg QD	Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg QD	Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg QD	Febuxostat 120 mg, orally, once daily.
Placebo QD	Placebo, orally, once daily

Baseline Measures

	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD	Total
Number of Participants   [units: participants]	37	40	38	38	153
Age, Customized   [units: subjects]
<45 years	8	10	7	12	37
45 years to <65 years	21	19	23	17	80
≥65 years	8	11	8	9	36
Age   [units: years] Mean ± Standard Deviation	52.2 ± 14.04	55.2 ± 13.09	56.2 ± 10.83	52.4 ± 12.63	54.0 ± 12.69
Gender   [units: subjects]
Female	4	2	5	6	17
Male	33	38	33	32	136
Race/Ethnicity, Customized   [units: subjects]
White	32	35	34	32	133
Black or African American	3	3	2	3	11
Hispanic	1	1	1	1	4
Asian	0	1	1	0	2
Other	1	0	0	2	3
Body Mass Index   [units: subjects]
≤25 kilogram per meter² (kg/m²)	2	3	3	0	8
>25 kg/m² to 30 kg/m²	12	12	14	13	51
>30 kg/m² to 35 kg/m²	16	12	12	16	56
>35 kg/m² to 40 kg/m²	4	7	5	6	22
>40 kg/m²	3	6	3	3	15
missing	0	0	1	0	1

1.  Primary:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.

2.  Secondary:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.

3.  Secondary:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.

4.  Secondary:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.

5.  Secondary:

Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.

6.  Secondary:

Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.

7.  Secondary:

Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit

8.  Secondary:

Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.

9.  Secondary:

Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.

10.  Secondary:

Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.