Trial Outcomes & Findings for Long-Term Safety of Febuxostat in Subjects With Gout. (NCT NCT00174941)
NCT ID: NCT00174941
Last Updated: 2011-01-27
Results Overview
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.
COMPLETED
PHASE2
116 participants
Month 6
2011-01-27
Participant Flow
Subjects were enrolled at 23 investigational sites in the United States from 21 March 2001 to 29 December 2006
Subjects were to have completed 4 weeks of double-blind dosing in Study TMX-00-004 (NCT00174967) before enrollment in once daily (QD) treatment groups. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.
Participant milestones
| Measure |
Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
79
|
29
|
116
|
|
Overall Study
COMPLETED
|
6
|
41
|
11
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
38
|
18
|
58
|
Reasons for withdrawal
| Measure |
Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
10
|
2
|
13
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
2
|
5
|
|
Overall Study
Personal Reason(s)
|
0
|
14
|
8
|
22
|
|
Overall Study
Gout Flare
|
0
|
4
|
4
|
8
|
|
Overall Study
Reason Not Specified
|
1
|
6
|
2
|
9
|
Baseline Characteristics
Long-Term Safety of Febuxostat in Subjects With Gout.
Baseline characteristics by cohort
| Measure |
Febuxostat 40 mg QD
n=8 Participants
Febuxostat 40 mg orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=79 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level
|
Febuxostat 120 mg QD
n=29 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 years
|
2 Subjects
n=99 Participants
|
20 Subjects
n=107 Participants
|
9 Subjects
n=206 Participants
|
31 Subjects
n=7 Participants
|
|
Age, Customized
45 to <65 years
|
4 Subjects
n=99 Participants
|
40 Subjects
n=107 Participants
|
15 Subjects
n=206 Participants
|
59 Subjects
n=7 Participants
|
|
Age, Customized
≥65 years
|
2 Subjects
n=99 Participants
|
19 Subjects
n=107 Participants
|
5 Subjects
n=206 Participants
|
26 Subjects
n=7 Participants
|
|
Age Continuous
|
54.5 years
STANDARD_DEVIATION 11.44 • n=99 Participants
|
53.9 years
STANDARD_DEVIATION 12.85 • n=107 Participants
|
51.3 years
STANDARD_DEVIATION 13.01 • n=206 Participants
|
53.3 years
STANDARD_DEVIATION 12.74 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11.0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
105.0 Participants
n=7 Participants
|
|
History of Kidney Stone
Yes
|
0 Subjects
n=99 Participants
|
11 Subjects
n=107 Participants
|
3 Subjects
n=206 Participants
|
14 Subjects
n=7 Participants
|
|
History of Kidney Stone
No
|
8 Subjects
n=99 Participants
|
68 Subjects
n=107 Participants
|
26 Subjects
n=206 Participants
|
102 Subjects
n=7 Participants
|
|
Presence of Tophus
Yes
|
1 Subjects
n=99 Participants
|
13 Subjects
n=107 Participants
|
12 Subjects
n=206 Participants
|
26 Subjects
n=7 Participants
|
|
Presence of Tophus
No
|
7 Subjects
n=99 Participants
|
66 Subjects
n=107 Participants
|
17 Subjects
n=206 Participants
|
90 Subjects
n=7 Participants
|
|
Race/Ethnicity
Asian
|
0 Subjects
n=99 Participants
|
0 Subjects
n=107 Participants
|
2 Subjects
n=206 Participants
|
2 Subjects
n=7 Participants
|
|
Race/Ethnicity
Black or African American
|
1 Subjects
n=99 Participants
|
5 Subjects
n=107 Participants
|
3 Subjects
n=206 Participants
|
9 Subjects
n=7 Participants
|
|
Race/Ethnicity
White
|
7 Subjects
n=99 Participants
|
71 Subjects
n=107 Participants
|
21 Subjects
n=206 Participants
|
99 Subjects
n=7 Participants
|
|
Race/Ethnicity
Hispanic
|
0 Subjects
n=99 Participants
|
2 Subjects
n=107 Participants
|
1 Subjects
n=206 Participants
|
3 Subjects
n=7 Participants
|
|
Race/Ethnicity
Other
|
0 Subjects
n=99 Participants
|
1 Subjects
n=107 Participants
|
2 Subjects
n=206 Participants
|
3 Subjects
n=7 Participants
|
|
Renal Function
Normal
|
3 Subjects
n=99 Participants
|
33 Subjects
n=107 Participants
|
12 Subjects
n=206 Participants
|
48 Subjects
n=7 Participants
|
|
Renal Function
Impaired
|
5 Subjects
n=99 Participants
|
46 Subjects
n=107 Participants
|
17 Subjects
n=206 Participants
|
68 Subjects
n=7 Participants
|
|
Urine Uric Acid
Underexcretor
|
5 Subjects
n=99 Participants
|
62 Subjects
n=107 Participants
|
21 Subjects
n=206 Participants
|
88 Subjects
n=7 Participants
|
|
Urine Uric Acid
Overproducer
|
3 Subjects
n=99 Participants
|
16 Subjects
n=107 Participants
|
7 Subjects
n=206 Participants
|
26 Subjects
n=7 Participants
|
|
Urine Uric Acid
Missing
|
0 Subjects
n=99 Participants
|
1 Subjects
n=107 Participants
|
1 Subjects
n=206 Participants
|
2 Subjects
n=7 Participants
|
|
Body Mass Index
|
28.4 kiligram per meter² (kg/m²)
STANDARD_DEVIATION 2.78 • n=99 Participants
|
32.9 kiligram per meter² (kg/m²)
STANDARD_DEVIATION 5.28 • n=107 Participants
|
33.9 kiligram per meter² (kg/m²)
STANDARD_DEVIATION 6.82 • n=206 Participants
|
32.9 kiligram per meter² (kg/m²)
STANDARD_DEVIATION 5.69 • n=7 Participants
|
|
Serum Urate
|
9.58 mg/dL
STANDARD_DEVIATION 1.18 • n=99 Participants
|
9.48 mg/dL
STANDARD_DEVIATION 1.04 • n=107 Participants
|
10.23 mg/dL
STANDARD_DEVIATION 1.74 • n=206 Participants
|
9.7 mg/dL
STANDARD_DEVIATION 1.30 • n=7 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the 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=10 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=58 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=17 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=85 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.
|
50 percentage of subjects
|
93 percentage of subjects
|
65 percentage of subjects
|
82 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 12Population: Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 12 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=7 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=55 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=18 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=80 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.
|
57 percentage of subjects
|
85 percentage of subjects
|
67 percentage of subjects
|
79 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 18Population: Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 18 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=8 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=50 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=14 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=72 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.
|
50 percentage of subjects
|
82 percentage of subjects
|
57 percentage of subjects
|
74 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 24Population: Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 24 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=8 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=49 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=13 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=70 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.
|
63 percentage of subjects
|
76 percentage of subjects
|
92 percentage of subjects
|
77 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 36Population: Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 36 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=6 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=45 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=13 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=64 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.
|
67 percentage of subjects
|
84 percentage of subjects
|
92 percentage of subjects
|
84 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 48Population: Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 48 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=6 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=39 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=13 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=58 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.
|
83 percentage of subjects
|
92 percentage of subjects
|
85 percentage of subjects
|
90 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 60Population: Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 60 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=6 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=41 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=11 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=58 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.
|
100 percentage of subjects
|
93 percentage of subjects
|
91 percentage of subjects
|
93 percentage of subjects
|
PRIMARY outcome
Timeframe: Last Visit on treatment (up to 66 months).Population: Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the 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.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=8 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=79 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=27 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=114 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.
|
100 percentage of subjects
|
82 percentage of subjects
|
81 percentage of subjects
|
83 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the 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=10 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=58 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=17 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=85 Participants
|
|---|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.
|
-35.9 percent change from baseline
Standard Deviation 9.55
|
-50.6 percent change from baseline
Standard Deviation 9.84
|
-47.6 percent change from baseline
Standard Deviation 19.6
|
-48.3 percent change from baseline
Standard Deviation 13.07
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=7 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=55 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=18 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=80 Participants
|
|---|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.
|
-35.0 percentage of subjects
Standard Deviation 13.16
|
-49.7 percentage of subjects
Standard Deviation 9.26
|
-49.3 percentage of subjects
Standard Deviation 15.77
|
-48.3 percentage of subjects
Standard Deviation 11.94
|
SECONDARY outcome
Timeframe: Baseline and Month 18Population: Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=8 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=50 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=14 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=72 Participants
|
|---|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.
|
-35.5 percent change from baseline
Standard Deviation 16.35
|
-48.7 percent change from baseline
Standard Deviation 11.12
|
-39.5 percent change from baseline
Standard Deviation 19.36
|
-45.4 percent change from baseline
Standard Deviation 14.35
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=8 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=49 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=13 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=70 Participants
|
|---|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.
|
-38.9 percent change from baseline
Standard Deviation 19.41
|
-46.7 percent change from baseline
Standard Deviation 11.59
|
-54.7 percent change from baseline
Standard Deviation 12.02
|
-47.3 percent change from baseline
Standard Deviation 13.24
|
SECONDARY outcome
Timeframe: Baseline and Month 36Population: Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=6 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=45 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=13 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=64 Participants
|
|---|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.
|
-43.0 percent change from baseline
Standard Deviation 9.14
|
-46.9 percent change from baseline
Standard Deviation 13.35
|
-56.4 percent change from baseline
Standard Deviation 13.76
|
-48.4 percent change from baseline
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Baseline and Month 48Population: Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=6 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=39 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=13 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=58 Participants
|
|---|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.
|
-50.0 percent change from baseline
Standard Deviation 4.16
|
-50.3 percent change from baseline
Standard Deviation 10.61
|
-53.8 percent change from baseline
Standard Deviation 16.41
|
-51.1 percent change from baseline
Standard Deviation 11.64
|
SECONDARY outcome
Timeframe: Baseline and Month 60Population: Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.
Outcome measures
| Measure |
Febuxostat 40 mg QD
n=6 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=41 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=11 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=58 Participants
|
|---|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.
|
-45.5 percent change from baseline
Standard Deviation 8.70
|
-51.1 percent change from baseline
Standard Deviation 13.21
|
-59.0 percent change from baseline
Standard Deviation 18.74
|
-52.0 percent change from baseline
Standard Deviation 14.32
|
SECONDARY outcome
Timeframe: Baseline and Last Visit on treatment (up to 66 months).Population: Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
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=8 Participants
Febuxostat 40 mg, orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=79 Participants
Febuxostat 80 mg, orally, once daily, based on serum urate level.
|
Febuxostat 120 mg QD
n=27 Participants
Febuxostat 120 mg, orally, once daily, based on serum urate level.
|
Total Febuxostat
n=114 Participants
|
|---|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline at Final Visit.
|
-49.2 percent change from baseline
Standard Deviation 7.10
|
-47.1 percent change from baseline
Standard Deviation 16.42
|
-50.7 percent change from baseline
Standard Deviation 19.12
|
-48.1 percent change from baseline
Standard Deviation 16.61
|
Adverse Events
Febuxostat 40 mg QD
Febuxostat 80 mg QD
Febuxostat 120 mg QD
Febuxostat Total
Serious adverse events
| Measure |
Febuxostat 40 mg QD
n=12 participants at risk
Febuxostat 40 mg taken orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=116 participants at risk
Febuxostat 80 mg, taken orally, once daily, based on serum urate level
|
Febuxostat 120 mg QD
n=37 participants at risk
Febuxostat 120 mg, taken orally, once daily, based on serum urate level
|
Febuxostat Total
n=116 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Conduction Disorders
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
0.00%
0/12
|
4.3%
5/116
|
0.00%
0/37
|
4.3%
5/116
|
|
Gastrointestinal disorders
Duodenal and Small Intestinal Stenosis and Obstruction
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Gastrointestinal disorders
Gastrointestinal Ulcers and Perforation, Site Unspecified
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Gastrointestinal disorders
Intestinal Ulcers & Perforation not elsewhere classified (NEC)
|
8.3%
1/12
|
0.00%
0/116
|
0.00%
0/37
|
0.86%
1/116
|
|
General disorders
Pain and Discomfort NEC
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Hepatobiliary disorders
Cholecystitis and Cholelithiasis
|
8.3%
1/12
|
0.86%
1/116
|
0.00%
0/37
|
1.7%
2/116
|
|
Infections and infestations
Abdominal and Gastrointestinal Infections
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Infections and infestations
Lower Respiratory Tract and Lung Infections
|
8.3%
1/12
|
0.86%
1/116
|
0.00%
0/37
|
1.7%
2/116
|
|
Infections and infestations
Sepsis, Bacteraemia, Viraemia, and Infections
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Injury, poisoning and procedural complications
Cerebral Injuries NEC
|
0.00%
0/12
|
0.00%
0/116
|
2.7%
1/37
|
0.86%
1/116
|
|
Injury, poisoning and procedural complications
Fractures and Dislocations NEC
|
0.00%
0/12
|
0.00%
0/116
|
2.7%
1/37
|
0.86%
1/116
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries NEC
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Injury, poisoning and procedural complications
Radiation Injuries
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorders
|
0.00%
0/12
|
0.00%
0/116
|
2.7%
1/37
|
0.86%
1/116
|
|
Musculoskeletal and connective tissue disorders
Joint Related Disorders NEC
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathies
|
0.00%
0/12
|
0.86%
1/116
|
2.7%
1/37
|
1.7%
2/116
|
|
Musculoskeletal and connective tissue disorders
Pathological Fractures and Complications
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Musculoskeletal and connective tissue disorders
Spine and Neck Deformities
|
8.3%
1/12
|
0.00%
0/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and Oral Cavity Neoplasms Malignant
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Neoplasms Malignant
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory Tract and Pleural Neoplasms Benign NEC
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Neoplasms Malignant & Unspecified (Excluding Melanoma)
|
0.00%
0/12
|
0.00%
0/116
|
2.7%
1/37
|
0.86%
1/116
|
|
Nervous system disorders
Alzheimer's Disease (Including Subtypes)
|
0.00%
0/12
|
0.86%
1/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Nervous system disorders
Central Nervous System Hemorrhages & Cerebrovascular Accidents
|
8.3%
1/12
|
0.00%
0/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Psychiatric disorders
Depressive Disorders
|
8.3%
1/12
|
0.00%
0/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Renal and urinary disorders
Bladder and Urethral Symptoms
|
8.3%
1/12
|
0.00%
0/116
|
0.00%
0/37
|
0.86%
1/116
|
Other adverse events
| Measure |
Febuxostat 40 mg QD
n=12 participants at risk
Febuxostat 40 mg taken orally, once daily, based on serum urate level.
|
Febuxostat 80 mg QD
n=116 participants at risk
Febuxostat 80 mg, taken orally, once daily, based on serum urate level
|
Febuxostat 120 mg QD
n=37 participants at risk
Febuxostat 120 mg, taken orally, once daily, based on serum urate level
|
Febuxostat Total
n=116 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12
|
7.8%
9/116
|
2.7%
1/37
|
8.6%
10/116
|
|
Investigations
Liver Function Analyses
|
0.00%
0/12
|
3.4%
4/116
|
5.4%
2/37
|
5.2%
6/116
|
|
Gastrointestinal disorders
Gastrointestinal Atonic and Hypomotility Disorders NEC
|
0.00%
0/12
|
4.3%
5/116
|
0.00%
0/37
|
4.3%
5/116
|
|
Nervous system disorders
Headaches NEC
|
0.00%
0/12
|
4.3%
5/116
|
0.00%
0/37
|
4.3%
5/116
|
|
Metabolism and nutrition disorders
Hyperlipidaemias NEC
|
8.3%
1/12
|
2.6%
3/116
|
0.00%
0/37
|
3.4%
4/116
|
|
Investigations
White Blood Cell Analyses
|
0.00%
0/12
|
2.6%
3/116
|
0.00%
0/37
|
2.6%
3/116
|
|
Musculoskeletal and connective tissue disorders
Muscle Related Signs and Symptoms NEC
|
0.00%
0/12
|
2.6%
3/116
|
0.00%
0/37
|
2.6%
3/116
|
|
Renal and urinary disorders
Renal Lithiasis
|
8.3%
1/12
|
1.7%
2/116
|
0.00%
0/37
|
2.6%
3/116
|
|
Skin and subcutaneous tissue disorders
Rashes, Eruptions and Exanthems
|
8.3%
1/12
|
1.7%
2/116
|
0.00%
0/37
|
2.6%
3/116
|
|
Gastrointestinal disorders
Gastrointestinal Signs and Symptoms
|
0.00%
0/12
|
2.6%
3/116
|
2.7%
1/37
|
2.6%
3/116
|
|
Gastrointestinal disorders
Nausea and Vomiting Symptoms
|
0.00%
0/12
|
1.7%
2/116
|
0.00%
0/37
|
1.7%
2/116
|
|
General disorders
Oedema NEC
|
0.00%
0/12
|
1.7%
2/116
|
0.00%
0/37
|
1.7%
2/116
|
|
Investigations
Triglyceride Analyses
|
0.00%
0/12
|
1.7%
2/116
|
0.00%
0/37
|
1.7%
2/116
|
|
Musculoskeletal and connective tissue disorders
Arthropathies
|
8.3%
1/12
|
0.86%
1/116
|
0.00%
0/37
|
1.7%
2/116
|
|
Musculoskeletal and connective tissue disorders
Joint Related Signs and Symptoms
|
0.00%
0/12
|
1.7%
2/116
|
0.00%
0/37
|
1.7%
2/116
|
|
Musculoskeletal and connective tissue disorders
Muscle Pains
|
0.00%
0/12
|
0.00%
0/116
|
5.4%
2/37
|
1.7%
2/116
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Signs and Symptoms NEC
|
0.00%
0/12
|
1.7%
2/116
|
0.00%
0/37
|
1.7%
2/116
|
|
Investigations
Blood Amylase Increased
|
8.3%
1/12
|
0.00%
0/116
|
0.00%
0/37
|
0.86%
1/116
|
|
Injury, poisoning and procedural complications
Skin Injuries NEC
|
0.00%
0/12
|
0.00%
0/116
|
2.7%
1/37
|
0.86%
1/116
|
|
Investigations
Weight Increased
|
0.00%
0/12
|
0.00%
0/116
|
2.7%
1/37
|
0.86%
1/116
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/12
|
0.00%
0/116
|
2.7%
1/37
|
0.86%
1/116
|
Additional Information
Sr VP, Clinical Science
Takeda Global Research & Development Center, Inc.
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