Trial Outcomes & Findings for Efficacy and Safety of Oral Febuxostat in Participants With Gout (NCT NCT00430248)
NCT ID: NCT00430248
Last Updated: 2012-02-02
Results Overview
The percentage of subjects whose serum urate level 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2269 participants
Primary outcome timeframe
Last Visit on treatment (up to 6 months)
Results posted on
2012-02-02
Participant Flow
Subjects were enrolled at 324 sites in the United States from 16 February 2007 to 12 March 2008.
Subjects who were currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups.
Participant milestones
| Measure |
Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Overall Study
STARTED
|
757
|
756
|
756
|
|
Overall Study
COMPLETED
|
632
|
598
|
621
|
|
Overall Study
NOT COMPLETED
|
125
|
158
|
135
|
Reasons for withdrawal
| Measure |
Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
49
|
61
|
64
|
|
Overall Study
Protocol Violation
|
10
|
2
|
4
|
|
Overall Study
Personal Reasons
|
12
|
24
|
9
|
|
Overall Study
Lost to Follow-up
|
28
|
33
|
28
|
|
Overall Study
Therapeutic Failure
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
20
|
16
|
|
Overall Study
Inclusion/Exclusion Criteria Not Met
|
0
|
2
|
0
|
|
Overall Study
Gout Flare
|
3
|
7
|
2
|
|
Overall Study
Reason Not Specified
|
8
|
8
|
11
|
Baseline Characteristics
Efficacy and Safety of Oral Febuxostat in Participants With Gout
Baseline characteristics by cohort
| Measure |
Febuxostat 40 mg QD
n=757 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=756 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=756 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
Total
n=2269 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 years of age
|
192 subjects
n=99 Participants
|
196 subjects
n=107 Participants
|
180 subjects
n=206 Participants
|
568 subjects
n=7 Participants
|
|
Age, Customized
45 to <65 years of age
|
450 subjects
n=99 Participants
|
432 subjects
n=107 Participants
|
445 subjects
n=206 Participants
|
1327 subjects
n=7 Participants
|
|
Age, Customized
≥65 years of age
|
115 subjects
n=99 Participants
|
128 subjects
n=107 Participants
|
131 subjects
n=206 Participants
|
374 subjects
n=7 Participants
|
|
Age Continuous
|
52.5 years
STANDARD_DEVIATION 11.68 • n=99 Participants
|
53.0 years
STANDARD_DEVIATION 11.79 • n=107 Participants
|
52.9 years
STANDARD_DEVIATION 11.73 • n=206 Participants
|
52.8 years
STANDARD_DEVIATION 11.73 • n=7 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
128 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
722 Participants
n=99 Participants
|
710 Participants
n=107 Participants
|
709 Participants
n=206 Participants
|
2141 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
149 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
710 Participants
n=99 Participants
|
707 Participants
n=107 Participants
|
702 Participants
n=206 Participants
|
2119 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
228 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
620 Participants
n=99 Participants
|
618 Participants
n=107 Participants
|
625 Participants
n=206 Participants
|
1863 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Body Mass Index
<18.5 kilograms per meter² (kg/m²)
|
0 subjects
n=99 Participants
|
1 subjects
n=107 Participants
|
1 subjects
n=206 Participants
|
2 subjects
n=7 Participants
|
|
Body Mass Index
18.5 kg/m² to <25 kg/m²
|
50 subjects
n=99 Participants
|
46 subjects
n=107 Participants
|
42 subjects
n=206 Participants
|
138 subjects
n=7 Participants
|
|
Body Mass Index
25 kg/m² to <30 kg/m²
|
215 subjects
n=99 Participants
|
232 subjects
n=107 Participants
|
236 subjects
n=206 Participants
|
683 subjects
n=7 Participants
|
|
Body Mass Index
≥30 kg/m²
|
490 subjects
n=99 Participants
|
476 subjects
n=107 Participants
|
476 subjects
n=206 Participants
|
1442 subjects
n=7 Participants
|
|
Body Mass Index
Missing
|
2 subjects
n=99 Participants
|
1 subjects
n=107 Participants
|
1 subjects
n=206 Participants
|
4 subjects
n=7 Participants
|
|
Cardiovascular Disease
No
|
336 subjects
n=99 Participants
|
316 subjects
n=107 Participants
|
320 subjects
n=206 Participants
|
972 subjects
n=7 Participants
|
|
Cardiovascular Disease
Yes
|
421 subjects
n=99 Participants
|
440 subjects
n=107 Participants
|
436 subjects
n=206 Participants
|
1297 subjects
n=7 Participants
|
|
Renal Function
Moderate Renal Impairment
|
130 subjects
n=99 Participants
|
136 subjects
n=107 Participants
|
136 subjects
n=206 Participants
|
402 subjects
n=7 Participants
|
|
Renal Function
Mild Renal Impairment
|
349 subjects
n=99 Participants
|
367 subjects
n=107 Participants
|
365 subjects
n=206 Participants
|
1081 subjects
n=7 Participants
|
|
Renal Function
Normal Renal Function
|
278 subjects
n=99 Participants
|
253 subjects
n=107 Participants
|
255 subjects
n=206 Participants
|
786 subjects
n=7 Participants
|
|
Mean Body Mass Index
|
32.9 kg/m²
STANDARD_DEVIATION 6.37 • n=99 Participants
|
32.9 kg/m²
STANDARD_DEVIATION 6.39 • n=107 Participants
|
32.7 kg/m²
STANDARD_DEVIATION 6.23 • n=206 Participants
|
32.8 kg/m²
STANDARD_DEVIATION 6.33 • n=7 Participants
|
|
Serum Urate
|
9.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 1.15 • n=99 Participants
|
9.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 1.20 • n=107 Participants
|
9.5 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 1.19 • n=206 Participants
|
9.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 1.18 • n=7 Participants
|
PRIMARY outcome
Timeframe: Last Visit on treatment (up to 6 months)Population: Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained.
The percentage of subjects whose serum urate level 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.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=757 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=756 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=755 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
|
45.2 percentage of subjects
|
67.1 percentage of subjects
|
42.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Last Visit on treatment (up to 6 months)Population: Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level.
The percentage of subjects with mild-to-moderate renal impairment 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.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=479 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=503 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=501 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl
|
49.7 percentage of subjects
|
71.6 percentage of subjects
|
42.3 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 2Population: Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 2 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=703 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=691 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=685 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.
|
49.1 percentage of subjects
|
74.1 percentage of subjects
|
43.2 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 4Population: Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 4 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=652 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=636 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=646 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.
|
47.1 percentage of subjects
|
75.2 percentage of subjects
|
45.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 6 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=618 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=596 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=616 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.
|
48.9 percentage of participants
|
75.3 percentage of participants
|
46.6 percentage of participants
|
SECONDARY outcome
Timeframe: Month 2Population: Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 2 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=703 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=691 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=685 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.
|
15.4 percentage of subjects
|
45.9 percentage of subjects
|
11.7 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 4Population: Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 4 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=652 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=636 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=646 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.
|
15.0 percentage of subjects
|
51.6 percentage of subjects
|
13.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 6 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=618 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=596 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=616 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.
|
19.3 percentage of subjects
|
49.7 percentage of subjects
|
14.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Last Visit on treatment (up to 6 months)Population: Analysis was performed on the ITT subjects with a post-baseline serum urate value.
The percentage of subjects whose serum urate level was \<5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=757 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=756 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=755 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.
|
16.5 percentage of subjects
|
44.0 percentage of subjects
|
13.2 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 2Population: Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 2 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=703 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=691 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=685 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit
|
2.1 percentage of subjects
|
17.5 percentage of subjects
|
1.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 4Population: Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 4 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=652 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=636 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=646 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit
|
2.0 percentage of subjects
|
18.6 percentage of subjects
|
1.4 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 6 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=618 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=596 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=616 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit
|
3.1 percentage of subjects
|
20.3 percentage of subjects
|
1.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Last Visit on treatment (up to 6 months)Population: Analysis was performed on the ITT subjects with a post-baseline serum urate value.
The percentage of subjects whose serum urate level was \<4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=757 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=756 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=755 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit
|
2.5 percentage of subjects
|
17.5 percentage of subjects
|
1.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and Month 2Population: Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.
Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=703 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=691 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=685 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.
|
-35.1 percent change from baseline
Standard Deviation 12.8
|
-44.5 percent change from baseline
Standard Deviation 15.5
|
-33.8 percent change from baseline
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.
Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=652 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=636 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=646 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit
|
-34.9 percent change from baseline
Standard Deviation 13.1
|
-45.5 percent change from baseline
Standard Deviation 15.6
|
-34.5 percent change from baseline
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.
Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=618 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=596 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=616 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.
|
-35.6 percent change from baseline
Standard Deviation 13.2
|
-45.1 percent change from baseline
Standard Deviation 16.0
|
-34.4 percent change from baseline
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Baseline and Last Visit on treatment (up to 6 months)Population: Analysis was performed on the ITT subjects with a post-baseline serum urate value.
The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=757 Participants
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
n=756 Participants
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
n=755 Participants
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.
|
-33.1 percent change from baseline
Standard Deviation 15.5
|
-40.6 percent change from baseline
Standard Deviation 19.9
|
-31.3 percent change from baseline
Standard Deviation 16.2
|
Adverse Events
Febuxostat 40 mg QD
Serious events: 19 serious events
Other events: 193 other events
Deaths: 0 deaths
Febuxostat 80 mg QD
Serious events: 28 serious events
Other events: 167 other events
Deaths: 0 deaths
Allopurinol 200 mg or 300 mg QD
Serious events: 31 serious events
Other events: 166 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Inner Ear Signs and Symptoms
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Gastrointestinal disorders
Acute and Chronic Pancreatitis
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Blood and lymphatic system disorders
Leukocytoses not elsewhere classified (NEC)
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Blood and lymphatic system disorders
Thrombocytopenias
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Cardiac disorders
Cardiac Conduction Disorders
|
0.00%
0/757
|
0.26%
2/756
|
0.00%
0/756
|
|
Cardiac disorders
Cardiac Hypertensive Complications
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Cardiac disorders
Coronary Artery Disorders NEC
|
0.26%
2/757
|
0.00%
0/756
|
0.26%
2/756
|
|
Cardiac disorders
Heart Failures NEC
|
0.26%
2/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Cardiac disorders
Ischaemic Coronary Artery Disorders
|
0.13%
1/757
|
0.26%
2/756
|
0.13%
1/756
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Gastrointestinal disorders
Benign Neoplasms GastrointestinaI (Excluding Oral Cavity)
|
0.13%
1/757
|
0.00%
0/756
|
0.00%
0/756
|
|
Gastrointestinal disorders
Dyspeptic Signs and Symptoms
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Gastrointestinal disorders
Gastrointestinal & Abdominal Pains (Excluding Oral and Throat)
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Gastrointestinal disorders
Gastrointestinal Ulcers and Perforation, Site Unspecified
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Gastrointestinal disorders
Intestinal Haemorrhages
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Gastrointestinal disorders
Intestinal Ulcers and Perforation NEC
|
0.26%
2/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Gastrointestinal disorders
Nausea and Vomiting Symptoms
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Gastrointestinal disorders
Non-Site Specific Gastrointestinal Haemorrhages
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
General disorders
General Signs and Symptoms NEC
|
0.13%
1/757
|
0.00%
0/756
|
0.00%
0/756
|
|
General disorders
Pain and Discomfort NEC
|
0.13%
1/757
|
0.26%
2/756
|
0.13%
1/756
|
|
Hepatobiliary disorders
Cholecystitis and Cholelithiasis
|
0.00%
0/757
|
0.00%
0/756
|
0.40%
3/756
|
|
Immune system disorders
Allergies to Food, Food Additives, Drugs and Other Chemicals
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Immune system disorders
Anaphylactic Responses
|
0.13%
1/757
|
0.00%
0/756
|
0.00%
0/756
|
|
Infections and infestations
Abdominal and Gastrointestinal Infections
|
0.26%
2/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Infections and infestations
Bacterial Infections NEC
|
0.13%
1/757
|
0.13%
1/756
|
0.26%
2/756
|
|
Infections and infestations
Lower Respiratory Tract and Lung Infections
|
0.13%
1/757
|
0.13%
1/756
|
0.40%
3/756
|
|
Infections and infestations
Sepsis, Bacteraemia, Viraemia, and Infections
|
0.00%
0/757
|
0.13%
1/756
|
0.13%
1/756
|
|
Injury, poisoning and procedural complications
Fractures and Dislocations NEC
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Injury, poisoning and procedural complications
Muscle, Tendon and Ligament Injuries
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries NEC
|
0.00%
0/757
|
0.26%
2/756
|
0.00%
0/756
|
|
Injury, poisoning and procedural complications
Non-Site Specific Procedural Complications
|
0.13%
1/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Injury, poisoning and procedural complications
Upper limb Fractures and Dislocations
|
0.00%
0/757
|
0.13%
1/756
|
0.13%
1/756
|
|
Metabolism and nutrition disorders
Purine Metabolism Disorders NEC
|
0.00%
0/757
|
0.13%
1/756
|
0.13%
1/756
|
|
Metabolism and nutrition disorders
Total Fluid Volume Decreased
|
0.13%
1/757
|
0.00%
0/756
|
0.00%
0/756
|
|
Musculoskeletal and connective tissue disorders
Joint Related Disorders NEC
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Musculoskeletal and connective tissue disorders
Joint Related Signs and Symptoms
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathies
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasms Malignant
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast and Nipple Neoplasms Malignant
|
0.13%
1/757
|
0.00%
0/756
|
0.00%
0/756
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic Neoplasms Malignant
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous System Neoplasms Unpecified Malignancy NEC
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nonsmall Cell Neoplasm Malignant/Respiratory Type Specified
|
0.00%
0/757
|
0.00%
0/756
|
0.13%
1/756
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Neoplasms Benign
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Neoplasms Malignant
|
0.00%
0/757
|
0.13%
1/756
|
0.40%
3/756
|
|
Nervous system disorders
Central Nervous System Hemorrhages & Cerebrovascular Accidents
|
0.00%
0/757
|
0.13%
1/756
|
0.13%
1/756
|
|
Nervous system disorders
Disturbances in Consciousness NEC
|
0.00%
0/757
|
0.00%
0/756
|
0.40%
3/756
|
|
Nervous system disorders
Increased Intracranial Pressure Disorders
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Nervous system disorders
Neurological Signs and Symptoms NEC
|
0.13%
1/757
|
0.00%
0/756
|
0.00%
0/756
|
|
Nervous system disorders
Transient Cerebrovascular Events
|
0.13%
1/757
|
0.13%
1/756
|
0.13%
1/756
|
|
Renal and urinary disorders
Renal Failure and Impairment
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Renal and urinary disorders
Renal Vascular and Ischaemic Conditions
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Reproductive system and breast disorders
Prostatic Signs, Symptoms and Disorders NEC
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasms and Obstruction
|
0.00%
0/757
|
0.13%
1/756
|
0.13%
1/756
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thrombotic and Embolic Conditions
|
0.00%
0/757
|
0.13%
1/756
|
0.00%
0/756
|
|
Vascular disorders
Aortic Aneurysms and Dissections
|
0.13%
1/757
|
0.00%
0/756
|
0.13%
1/756
|
Other adverse events
| Measure |
Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily for up to 6 months.
|
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 6 months.
|
Allopurinol 200 mg or 300 mg QD
Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
|
|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infections
|
9.4%
71/757
|
7.0%
53/756
|
7.5%
57/756
|
|
Investigations
Liver Function Analyses
|
8.3%
63/757
|
6.9%
52/756
|
6.6%
50/756
|
|
Gastrointestinal disorders
Diarrhoea (Excluding Infective)
|
5.9%
45/757
|
6.2%
47/756
|
7.5%
57/756
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissues Signs and Symptoms NEC
|
5.7%
43/757
|
5.0%
38/756
|
4.2%
32/756
|
Additional Information
Sr. VP, Clinical Sciences
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER