Trial Outcomes & Findings for Febuxostat Versus Allopurinol Control Trial in Subjects With Gout (NCT NCT00102440)
NCT ID: NCT00102440
Last Updated: 2012-02-02
Results Overview
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.
COMPLETED
PHASE3
760 participants
Last 3 Visits (up to 52 weeks)
2012-02-02
Participant Flow
Subjects were enrolled at 112 investigative sites, 106 in the United States and 6 in Canada, from 11 July 2002 to 20 February 2004.
Subjects currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollment in once daily (QD) treatment groups.
Participant milestones
| Measure |
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
256
|
251
|
253
|
|
Overall Study
COMPLETED
|
168
|
153
|
187
|
|
Overall Study
NOT COMPLETED
|
88
|
98
|
66
|
Reasons for withdrawal
| Measure |
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
18
|
21
|
|
Overall Study
Adverse Event
|
16
|
23
|
8
|
|
Overall Study
Gout Flare
|
10
|
28
|
9
|
|
Overall Study
Personal Reason(s)
|
19
|
13
|
13
|
|
Overall Study
Other
|
11
|
14
|
14
|
|
Overall Study
Protocol Violation
|
7
|
2
|
1
|
Baseline Characteristics
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
Baseline characteristics by cohort
| Measure |
Febuxostat 80 mg QD
n=256 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=251 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=253 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
Total
n=760 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 years
|
75 subjects
n=5 Participants
|
71 subjects
n=7 Participants
|
84 subjects
n=5 Participants
|
230 subjects
n=4 Participants
|
|
Age, Customized
45 years to <65 years
|
140 subjects
n=5 Participants
|
133 subjects
n=7 Participants
|
125 subjects
n=5 Participants
|
398 subjects
n=4 Participants
|
|
Age, Customized
≥65 years
|
41 subjects
n=5 Participants
|
47 subjects
n=7 Participants
|
44 subjects
n=5 Participants
|
132 subjects
n=4 Participants
|
|
Age Continuous
|
51.8 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 12.12 • n=7 Participants
|
51.6 years
STANDARD_DEVIATION 12.63 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 12.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
243 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
729 Participants
n=4 Participants
|
|
Body Mass Index
<18.5 kilogram per meter² (kg/m²)
|
0 subjects
n=5 Participants
|
0 subjects
n=7 Participants
|
0 subjects
n=5 Participants
|
0 subjects
n=4 Participants
|
|
Body Mass Index
18.5 kg/m² to <25 kg/m²
|
15 subjects
n=5 Participants
|
12 subjects
n=7 Participants
|
7 subjects
n=5 Participants
|
34 subjects
n=4 Participants
|
|
Body Mass Index
25 kg/m² to <30 kg/m²
|
75 subjects
n=5 Participants
|
87 subjects
n=7 Participants
|
89 subjects
n=5 Participants
|
251 subjects
n=4 Participants
|
|
Body Mass Index
≥30 kg/m²
|
166 subjects
n=5 Participants
|
152 subjects
n=7 Participants
|
154 subjects
n=5 Participants
|
472 subjects
n=4 Participants
|
|
Body Mass Index
missing
|
0 subjects
n=5 Participants
|
0 subjects
n=7 Participants
|
3 subjects
n=5 Participants
|
3 subjects
n=4 Participants
|
|
Calculated Creatinine Clearance
<50 milliliters per minute (mL/min)
|
13 subjects
n=5 Participants
|
8 subjects
n=7 Participants
|
13 subjects
n=5 Participants
|
34 subjects
n=4 Participants
|
|
Calculated Creatinine Clearance
50 mL/min to <80 mL/min
|
77 subjects
n=5 Participants
|
90 subjects
n=7 Participants
|
68 subjects
n=5 Participants
|
235 subjects
n=4 Participants
|
|
Calculated Creatinine Clearance
80 mL/min to <120 mL/min
|
138 subjects
n=5 Participants
|
130 subjects
n=7 Participants
|
140 subjects
n=5 Participants
|
408 subjects
n=4 Participants
|
|
Calculated Creatinine Clearance
≥120 mL/min
|
28 subjects
n=5 Participants
|
23 subjects
n=7 Participants
|
29 subjects
n=5 Participants
|
80 subjects
n=4 Participants
|
|
Calculated Creatinine Clearance
missing
|
0 subjects
n=5 Participants
|
0 subjects
n=7 Participants
|
3 subjects
n=5 Participants
|
3 subjects
n=4 Participants
|
|
Presence of Primary Palpable Tophus
Yes
|
52 subjects
n=5 Participants
|
53 subjects
n=7 Participants
|
46 subjects
n=5 Participants
|
151 subjects
n=4 Participants
|
|
Presence of Primary Palpable Tophus
No, but other tophi present
|
1 subjects
n=5 Participants
|
2 subjects
n=7 Participants
|
3 subjects
n=5 Participants
|
6 subjects
n=4 Participants
|
|
Presence of Primary Palpable Tophus
No and no other tophi present
|
203 subjects
n=5 Participants
|
196 subjects
n=7 Participants
|
204 subjects
n=5 Participants
|
603 subjects
n=4 Participants
|
|
Race/Ethnicity
White
|
193 subjects
n=5 Participants
|
199 subjects
n=7 Participants
|
195 subjects
n=5 Participants
|
587 subjects
n=4 Participants
|
|
Race/Ethnicity
Black or African American
|
24 subjects
n=5 Participants
|
20 subjects
n=7 Participants
|
18 subjects
n=5 Participants
|
62 subjects
n=4 Participants
|
|
Race/Ethnicity
Hispanic
|
22 subjects
n=5 Participants
|
17 subjects
n=7 Participants
|
19 subjects
n=5 Participants
|
58 subjects
n=4 Participants
|
|
Race/Ethnicity
Asian
|
10 subjects
n=5 Participants
|
9 subjects
n=7 Participants
|
6 subjects
n=5 Participants
|
25 subjects
n=4 Participants
|
|
Race/Ethnicity
Other
|
7 subjects
n=5 Participants
|
6 subjects
n=7 Participants
|
15 subjects
n=5 Participants
|
28 subjects
n=4 Participants
|
PRIMARY outcome
Timeframe: Last 3 Visits (up to 52 weeks)Population: Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 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.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=255 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=250 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=251 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
|
53 Percentage of subjects
|
62 Percentage of subjects
|
21 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 28Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.
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.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=186 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=159 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=199 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit
|
72 Percentage of subjects
|
82 Percentage of subjects
|
42 Percentage of subjects
|
SECONDARY outcome
Timeframe: Week 52Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.
Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Week 52 visit was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=159 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=145 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=178 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit
|
81 Percentage of subjects
|
82 Percentage of subjects
|
39 Percentage of subjects
|
SECONDARY outcome
Timeframe: Final Visit (up to 52 weeks)Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.
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. The timing of the final visit may have differed for each subject.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=249 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=242 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=242 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit
|
74 Percentage of subjects
|
80 Percentage of subjects
|
36 Percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.
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.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=186 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=159 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=199 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Urate Levels at Week 28.
|
-46.3 percent change from baseline
Standard Deviation 15.76
|
-53.5 percent change from baseline
Standard Deviation 18.20
|
-34.8 percent change from baseline
Standard Deviation 12.92
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.
Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as \[(week 52 - baseline levels/baseline)\]\*100 and summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=159 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=145 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=178 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Urate Levels at Week 52.
|
-47.7 percent change from baseline
Standard Deviation 17.50
|
-53.0 percent change from baseline
Standard Deviation 19.31
|
-34.8 percent change from baseline
Standard Deviation 13.56
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to 52 weeks)Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.
The percent change in serum urate from baseline to the Final visit was calculated as \[(Final Visit - baseline levels/baseline)\]\*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=249 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=242 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=242 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Urate Levels at Final Visit
|
-44.7 percent change from baseline
Standard Deviation 19.10
|
-51.5 percent change from baseline
Standard Deviation 19.91
|
-33.0 percent change from baseline
Standard Deviation 15.33
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.
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.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=36 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=28 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=33 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
|
-29.5 percent change from baseline
Interval -66.0 to 4.1
|
-49.5 percent change from baseline
Interval -80.0 to -34.9
|
-28.6 percent change from baseline
Interval -54.9 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.
The percent change from baseline in primary tophus size as determined by physical measurement was calculated as \[(Week 52 - baseline sizes)/baseline\]\*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 52 visit, the size was assumed to be zero.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=32 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=26 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=30 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
|
-83.4 percent change from baseline
Interval -100.0 to -15.6
|
-65.5 percent change from baseline
Interval -85.5 to -38.9
|
-49.7 percent change from baseline
Interval -96.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to 52 weeks)Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.
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.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=50 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=51 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=44 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
|
-51.7 percent change from baseline
Interval -100.0 to -8.3
|
-43.8 percent change from baseline
Interval -83.0 to 0.0
|
-39.6 percent change from baseline
Interval -65.0 to 1.5
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.
The 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 no longer palpable at the Week 28 visit, the total count was assumed to be zero.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=38 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=30 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=37 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.
|
0.0 number of tophi
Interval 0.0 to 0.0
|
0.0 number of tophi
Interval -1.0 to 0.0
|
0.0 number of tophi
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.
The change from baseline at Week 52 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 no longer palpable at the Week 52 visit, the total count was assumed to be zero.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=33 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=28 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=35 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.
|
0.0 number of tophi
Interval -1.0 to 0.0
|
-1.0 number of tophi
Interval -1.0 to 0.0
|
0.0 number of tophi
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to 52 weeks)Population: Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.
Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at 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.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=52 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=53 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=47 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.
|
0.0 number of tophi
Interval -1.0 to 0.0
|
0.0 number of tophi
Interval -1.0 to 0.0
|
0.0 number of tophi
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Weeks 8 through 52Population: Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 52.
The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=228 Participants
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=215 Participants
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=234 Participants
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.
|
64 percentage of subjects
|
70 percentage of subjects
|
64 percentage of subjects
|
Adverse Events
Febuxostat 80 mg QD
Febuxostat 120 mg QD
Allopurinol 300 mg QD
Serious adverse events
| Measure |
Febuxostat 80 mg QD
n=256 participants at risk
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=251 participants at risk
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=253 participants at risk
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Disorders not elsewhere classified (NEC)
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Cardiac disorders
Coronary Artery Disorders NEC
|
0.00%
0/256
|
0.00%
0/251
|
1.6%
4/253
|
|
Cardiac disorders
Heart Failures NEC
|
1.2%
3/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Cardiac disorders
Ischaemic Coronary Artery Disorders NEC
|
1.2%
3/256
|
0.80%
2/251
|
0.79%
2/253
|
|
Cardiac disorders
Rate and Rhythm Disorders NEC
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
0.39%
1/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Cardiac disorders
Ventricular Arrhythmias and Cardiac Arrest
|
0.00%
0/256
|
0.80%
2/251
|
0.40%
1/253
|
|
Gastrointestinal disorders
Acute and Chronic Pancreatitis
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Gastrointestinal disorders
Gastrointestinal Fistulae
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Gastrointestinal disorders
Gastrointestinal Ulcers and Perforation, Site Unspecified
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Gastrointestinal disorders
Intestinal Haemorrhages
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Gastrointestinal disorders
Intestinal Ulcers and Perforation NEC
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Gastrointestinal disorders
Peritoneal and Retroperitoneal Haemorrhages
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Gastrointestinal disorders
Umbilical Hernias
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
General disorders
Febrile Disorders
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Immune system disorders
Allergies to Food, Food Additives, Drugs and Other Chemicals
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Infections and infestations
Abdominal and Gastrointestinal Infections
|
0.00%
0/256
|
0.40%
1/251
|
0.79%
2/253
|
|
Infections and infestations
Infections NEC
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Infections and infestations
Lower Respiratory Tract and Lung Infections
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Infections and infestations
Skin Structures and Soft Tissue Infections
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Infections and infestations
Staphylococcal Infections
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Infections and infestations
Urinary Tract Infections
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Infections and infestations
Viral Infections NEC
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Chest and Lung Injuries NEC
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries NEC
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Site Specific Injuries NEC
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Investigations
Coagulation and Bleeding Analyses
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Joint Related Signs and Symptoms
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Signs and Symptoms NEC
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathies
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Musculoskeletal and connective tissue disorders
Spine and Neck Deformities
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic Neoplasms Malignant
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Neoplasms Malignant
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular Neoplasms Malignant
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Nervous system disorders
Central Nervous System Vascular Disorders NEC
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Nervous system disorders
Central nervous system Hemorrhages & Cerebrovascular Accidents
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Nervous system disorders
Cervical Spinal Cord and Nerve Root Disorders
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Nervous system disorders
Disturbances in Consciousness NEC
|
0.00%
0/256
|
0.40%
1/251
|
0.40%
1/253
|
|
Nervous system disorders
Encephalopathies NEC
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Renal and urinary disorders
Renal Failure and Impairment
|
0.78%
2/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Renal and urinary disorders
Renal Lithiasis
|
0.00%
0/256
|
0.00%
0/251
|
0.40%
1/253
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm and Obstruction
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax and Pleural Effusions NEC
|
0.39%
1/256
|
0.00%
0/251
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thrombotic and Embolic Conditions
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failures (Excluding [Excl] Neonatal)
|
0.39%
1/256
|
0.40%
1/251
|
0.00%
0/253
|
|
Vascular disorders
Peripheral Embolism and Thrombosis
|
0.00%
0/256
|
0.40%
1/251
|
0.00%
0/253
|
Other adverse events
| Measure |
Febuxostat 80 mg QD
n=256 participants at risk
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
|
Febuxostat 120 mg QD
n=251 participants at risk
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
|
Allopurinol 300 mg QD
n=253 participants at risk
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (Excl Infective)
|
10.5%
27/256
|
10.0%
25/251
|
6.3%
16/253
|
|
Gastrointestinal disorders
Nausea and Vomiting Symptoms
|
7.4%
19/256
|
5.2%
13/251
|
3.2%
8/253
|
|
General disorders
Oedema NEC
|
7.0%
18/256
|
3.2%
8/251
|
3.2%
8/253
|
|
Infections and infestations
Influenza Viral Infections
|
4.7%
12/256
|
5.2%
13/251
|
4.7%
12/253
|
|
Infections and infestations
Lower Respiratory Tract and Lung Infections
|
5.1%
13/256
|
2.8%
7/251
|
3.2%
8/253
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
30.1%
77/256
|
21.1%
53/251
|
28.5%
72/253
|
|
Injury, poisoning and procedural complications
Limb Injuries NEC (Including [Incl] Traumatic Amputation)
|
4.7%
12/256
|
4.0%
10/251
|
4.3%
11/253
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries NEC
|
4.3%
11/256
|
4.0%
10/251
|
4.7%
12/253
|
|
Investigations
Liver Function Analyses
|
5.1%
13/256
|
6.4%
16/251
|
4.7%
12/253
|
|
Musculoskeletal and connective tissue disorders
Joint Related Signs and Symptoms
|
15.2%
39/256
|
12.7%
32/251
|
14.6%
37/253
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Signs and Symptoms NEC
|
13.7%
35/256
|
15.1%
38/251
|
14.6%
37/253
|
|
Nervous system disorders
Headache NEC
|
9.0%
23/256
|
9.2%
23/251
|
8.7%
22/253
|
|
Nervous system disorders
Neurological Signs and Symptoms NEC
|
6.6%
17/256
|
3.6%
9/251
|
2.8%
7/253
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Signs and Symptoms
|
5.1%
13/256
|
4.0%
10/251
|
6.7%
17/253
|
|
Vascular disorders
Vascular Hypertensive Disorders NEC
|
2.7%
7/256
|
4.0%
10/251
|
5.5%
14/253
|
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