Trial Outcomes & Findings for Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010 (NCT NCT00175019)
NCT ID: NCT00175019
Last Updated: 2010-07-27
Results Overview
Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 1 visit was summarized.
COMPLETED
PHASE3
1086 participants
Month 1
2010-07-27
Participant Flow
Subjects were enrolled at 174 investigative sites, including 168 in the United States and 6 in Canada, from 28 July 2003 to 26 February 2007.
Subjects were to have completed either 28 weeks or 52 weeks of double-blind dosing in Study C02-009 (NCT00174915) or C02-010 (NCT00102440), respectively before enrollment.
Participant milestones
| Measure |
Febuxostat 80 mg QD
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
606
|
388
|
92
|
|
Overall Study
COMPLETED
|
412
|
217
|
35
|
|
Overall Study
NOT COMPLETED
|
194
|
171
|
57
|
Reasons for withdrawal
| Measure |
Febuxostat 80 mg QD
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
54
|
22
|
2
|
|
Overall Study
Protocol Violation
|
6
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
42
|
39
|
9
|
|
Overall Study
Did not continue under Amendment 4
|
1
|
1
|
2
|
|
Overall Study
Personal Reason(s)
|
39
|
31
|
8
|
|
Overall Study
Therapeutic Failure
|
10
|
38
|
22
|
|
Overall Study
Gout Flare
|
2
|
3
|
0
|
|
Overall Study
Reason Not Specified
|
40
|
34
|
11
|
Baseline Characteristics
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
Baseline characteristics by cohort
| Measure |
Febuxostat 80 mg QD
n=606 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=388 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=92 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
Total
n=1086 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
53.0 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 11.02 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 11.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
581 Participants
n=5 Participants
|
371 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
1042 Participants
n=4 Participants
|
|
Presence of Tophus
Present
|
116 participants
n=5 Participants
|
83 participants
n=7 Participants
|
15 participants
n=5 Participants
|
214 participants
n=4 Participants
|
|
Presence of Tophus
Absent
|
490 participants
n=5 Participants
|
305 participants
n=7 Participants
|
77 participants
n=5 Participants
|
872 participants
n=4 Participants
|
|
Race/Ethnicity
Asian
|
15 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Race/Ethnicity
Black or African American
|
47 participants
n=5 Participants
|
33 participants
n=7 Participants
|
16 participants
n=5 Participants
|
96 participants
n=4 Participants
|
|
Race/Ethnicity
White
|
499 participants
n=5 Participants
|
299 participants
n=7 Participants
|
64 participants
n=5 Participants
|
862 participants
n=4 Participants
|
|
Race/Ethnicity
Hispanic
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
7 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Race/Ethnicity
Other
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
1 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
Renal Function
Normal
|
593 participants
n=5 Participants
|
381 participants
n=7 Participants
|
92 participants
n=5 Participants
|
1066 participants
n=4 Participants
|
|
Renal Function
Impaired
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
0 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
31.9 kg/m²
STANDARD_DEVIATION 5.49 • n=5 Participants
|
34.1 kg/m²
STANDARD_DEVIATION 6.71 • n=7 Participants
|
32.4 kg/m²
STANDARD_DEVIATION 5.58 • n=5 Participants
|
31.9 kg/m²
STANDARD_DEVIATION 5.49 • n=4 Participants
|
|
Serum Urate
|
9.65 mg/dL
STANDARD_DEVIATION 1.20 • n=5 Participants
|
10.05 mg/dL
STANDARD_DEVIATION 1.29 • n=7 Participants
|
9.83 mg/dL
STANDARD_DEVIATION 1.27 • n=5 Participants
|
9.81 mg/dL
STANDARD_DEVIATION 1.25 • n=4 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 1 visit and who had not changed from their initial treatment were included in the analysis.
Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 1 visit was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=620 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=277 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=139 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.
|
80.8 percentage of subjects
|
87.0 percentage of subjects
|
46.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 12Population: Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 12 visit and who had not changed from their initial treatment were included in the analysis.
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 80 mg QD
n=422 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=168 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=45 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.
|
88.9 percentage of subjects
|
86.3 percentage of subjects
|
82.2 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 24Population: Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 24 visit and who had not changed from their initial treatment were included in the analysis.
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 80 mg QD
n=364 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=141 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=42 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.
|
89.3 percentage of subjects
|
87.2 percentage of subjects
|
78.6 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 36Population: Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 36 visit and who had not changed from their initial treatment were included in the analysis.
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 80 mg QD
n=120 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=47 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=10 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.
|
90.8 percentage of subjects
|
91.5 percentage of subjects
|
90.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Last Visit on treatment (up to 40 months).Population: Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.
The percentage of subjects whose serum urate was \<6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=636 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=283 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=141 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.
|
70.8 percentage of subjects
|
82.0 percentage of subjects
|
32.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Last Visit on treatment (up to 40 months).Population: Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.
The percent change in serum urate from baseline to the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=636 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=283 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=141 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment.
|
-46.69 percent change from baseline
Standard Deviation 17.43
|
-52.99 percent change from baseline
Standard Deviation 19.12
|
-32.17 percent change from baseline
Standard Deviation 17.71
|
SECONDARY outcome
Timeframe: Month 12Population: Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 12 visit were included in the analysis.
The area of the primary tophus was calculated based on the length and width of the tophus measured at the Month 12 visit. The percent change from baseline in primary tophus size to the Month 12 visit was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=80 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=51 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=9 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline.
|
-82 percent change from baseline
Interval -100.0 to -40.0
|
-79 percent change from baseline
Interval -100.0 to -26.0
|
-56 percent change from baseline
Interval -100.0 to -16.0
|
SECONDARY outcome
Timeframe: Month 24Population: Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 24 visit were included in the analysis.
The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 24 visit. The percent change from baseline in primary tophus size to the Month 24 visit was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=64 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=32 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=4 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline.
|
-100 percent change from baseline
Interval -100.0 to -54.0
|
-96 percent change from baseline
Interval -100.0 to -52.0
|
-87 percent change from baseline
Interval -98.0 to -29.0
|
SECONDARY outcome
Timeframe: Month 36Population: Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 36 visit were included in the analysis.
The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 36 visit. The percent change from baseline in primary tophus size to the Month 36 visit was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=1 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline.
|
-83 percent change from baseline
Interval -83.0 to -83.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Final Visit (up to 40 months).Population: Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured while receiving their final stable treatment were included in the analysis.
The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and final visit. The percent change from baseline in primary tophus size to the final visit was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=107 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=76 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=14 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline.
|
-96 percent change from baseline
Interval -100.0 to -42.0
|
-84 percent change from baseline
Interval -100.0 to -16.0
|
-67 percent change from baseline
Interval -100.0 to 0.0
|
SECONDARY outcome
Timeframe: Final Visit (up to 40 months).Population: Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline who also had their tophi counted while receiving their final stable treatment were included in the analysis.
The number of tophi were counted at baseline and final visits. The percent change from baseline in the number of tophi to the final visit was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=107 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=76 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=14 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit.
|
-59.9 percent change from baseline
Standard Deviation 45.9
|
-58.3 percent change from baseline
Standard Deviation 42.5
|
-48.7 percent change from baseline
Standard Deviation 42.5
|
SECONDARY outcome
Timeframe: Month 12Population: Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.
The percentage of subjects requiring treatment for gout flare during the first twelve months of final stable treatment was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=606 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=388 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=92 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12.
|
29.4 percentage of subjects
|
42.5 percentage of subjects
|
28.3 percentage of subjects
|
SECONDARY outcome
Timeframe: After Month 12 to Final VisitPopulation: Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.
The percentage of subjects requiring treatment for gout flare after the first 12 months of final stable treatment was summarized.
Outcome measures
| Measure |
Febuxostat 80 mg QD
n=516 Participants
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=293 Participants
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=56 Participants
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Percentage of Subjects Requiring Treatment for Gout Flare After Month 12.
|
15.3 percentage of subjects
|
19.8 percentage of subjects
|
23.2 percentage of subjects
|
Adverse Events
Febuxostat 80 mg QD
Febuxostat 120 mg QD
Allopurinol QD
Serious adverse events
| Measure |
Febuxostat 80 mg QD
n=801 participants at risk
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=487 participants at risk
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=178 participants at risk
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia Deficiencies
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Blood and lymphatic system disorders
Thrombocytopenias
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Cardiac disorders
Aortic Valvular Disorders
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Cardiac disorders
Cardiac Conduction Disorders
|
0.25%
2/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Cardiac disorders
Cardiomyopathies
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Cardiac disorders
Coronary Artery Disorders not elsewhere classified (NEC)
|
1.6%
13/801
|
1.2%
6/487
|
0.56%
1/178
|
|
Cardiac disorders
Heart Failures NEC
|
0.37%
3/801
|
0.62%
3/487
|
0.56%
1/178
|
|
Cardiac disorders
Ischaemic Coronary Artery Disorders
|
2.1%
17/801
|
0.62%
3/487
|
1.1%
2/178
|
|
Cardiac disorders
Myocardial Disorders NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
0.12%
1/801
|
0.41%
2/487
|
0.56%
1/178
|
|
Cardiac disorders
Ventricular Arrhythmias and Cardiac Arrest
|
0.25%
2/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Congenital, familial and genetic disorders
Male Reproductive Tract Disorders Congenital
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Ear and labyrinth disorders
Hearing Losses
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Ear and labyrinth disorders
Inner Ear Signs and Symptoms
|
0.00%
0/801
|
0.41%
2/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Abdominal Hernias, Site Unspecified
|
0.00%
0/801
|
0.41%
2/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Benign Neoplasms GastrointestinaI (Excluding Oral Cavity)
|
0.12%
1/801
|
0.41%
2/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Colitis (Excluding Infective)
|
0.12%
1/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Diaphragmatic Hernias
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Duodenal and Small Intestinal Stenosis and Obstruction
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Gastrointestinal Atonic and Hypomotility Disorders NEC
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
General disorders
Gastrointestinal Disorders NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Gastrointestinal Stenosis and Obstruction NEC
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Inguinal Hernias
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Gastrointestinal disorders
Intestinal Ulcers and Perforation NEC
|
0.00%
0/801
|
0.00%
0/487
|
0.56%
1/178
|
|
Gastrointestinal disorders
Umbilical Hernias
|
0.00%
0/801
|
0.00%
0/487
|
0.56%
1/178
|
|
General disorders
Hernias NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
General disorders
Pain and Discomfort NEC
|
0.12%
1/801
|
0.41%
2/487
|
0.00%
0/178
|
|
Hepatobiliary disorders
Bile Duct Infections and Inflammations
|
0.00%
0/801
|
0.00%
0/487
|
0.56%
1/178
|
|
Hepatobiliary disorders
Cholecystitis and Cholelithiasis
|
0.87%
7/801
|
0.21%
1/487
|
0.56%
1/178
|
|
Hepatobiliary disorders
Hepatocellular Damage and Hepatitis NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Infections and infestations
Abdominal and Gastrointestinal Infections
|
0.37%
3/801
|
0.41%
2/487
|
1.1%
2/178
|
|
Infections and infestations
Bacterial Infections NEC
|
0.37%
3/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Infections and infestations
Bone and Joint Infections
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Infections and infestations
Cardiac Infections
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Infections and infestations
Infections NEC
|
0.62%
5/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Infections and infestations
Lower Respiratory Tract and Lung Infections
|
0.87%
7/801
|
0.41%
2/487
|
0.00%
0/178
|
|
Infections and infestations
Sepsis, Bacteraemia, Viraemia, and Fungaemia NEC
|
0.37%
3/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Infections and infestations
Staphylococcal Infections
|
0.25%
2/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Infections and infestations
Urinary Tract Infections
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Injury, poisoning and procedural complications
Cardiac and Vascular Procedural Complications
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Injury, poisoning and procedural complications
Cerebral Injuries NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Injury, poisoning and procedural complications
Limb Injuries NEC (Including Traumatic Amputation)
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Injury, poisoning and procedural complications
Lower limb Fractures and Dislocations
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Injury, poisoning and procedural complications
Muscle, Tendon and Ligament Injuries
|
0.12%
1/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries NEC
|
0.50%
4/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Injury, poisoning and procedural complications
Non-Site Specific Procedural Complications
|
0.50%
4/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Investigations
Neurologic Diagnostic Procedures
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Metabolism and nutrition disorders
Diabetes Mellitus (Including Subtypes)
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Metabolism and nutrition disorders
General Nutritional Disorders NEC
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Metabolism and nutrition disorders
Magnesium Metabolism Disorders
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Metabolism and nutrition disorders
Potassium Imbalance
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Musculoskeletal and connective tissue disorders
Bone Disorders NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorders
|
0.00%
0/801
|
0.41%
2/487
|
0.56%
1/178
|
|
Musculoskeletal and connective tissue disorders
Joint Related Disorders NEC
|
0.25%
2/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Musculoskeletal and connective tissue disorders
Muscle Related Signs and Symptoms NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathies
|
0.37%
3/801
|
0.82%
4/487
|
0.00%
0/178
|
|
Musculoskeletal and connective tissue disorders
Spine and Neck Deformities
|
0.12%
1/801
|
0.00%
0/487
|
1.1%
2/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell Lymphomas NEC
|
0.25%
2/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Neoplasms Malignant
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast and Nipple Neoplasms Malignant
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Musculoskeletal and connective tissue disorders
Colonic Neoplasms Malignant
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endocrine Neoplasms Benign NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign Site Unspecified NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Malignant/Respiratory Tract Cell Type Specified
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Neoplasms Malignant
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasms Benign
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasms Malignant (Excl Islet Cell and Carcinoid)
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Neoplasms Malignant
|
0.25%
2/801
|
0.41%
2/487
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Nervous system disorders
Central Nervous System Haemorrhages and CVA
|
0.75%
6/801
|
0.41%
2/487
|
0.00%
0/178
|
|
Nervous system disorders
Central Nervous System Vascular Disorders NEC
|
0.25%
2/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Nervous system disorders
Cervical Spinal Cord and Nerve Root Disorders
|
0.00%
0/801
|
0.00%
0/487
|
0.56%
1/178
|
|
Nervous system disorders
Disturbances in Consciousness NEC
|
0.25%
2/801
|
0.41%
2/487
|
0.00%
0/178
|
|
Nervous system disorders
Neurologic Visual Problems NEC
|
0.00%
0/801
|
0.00%
0/487
|
0.56%
1/178
|
|
Nervous system disorders
Neurological Signs and Symptoms NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Nervous system disorders
Paralysis and Paresis (Excl Cranial Nerve)
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Nervous system disorders
Transient Cerebrovascular Events
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Renal and urinary disorders
Renal Failure and Impairment
|
0.37%
3/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Renal and urinary disorders
Renal Lithiasis
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Psychiatric disorders
Renal Vascular and Ischaemic Conditions
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Abnormalities
|
0.25%
2/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasms and Obstruction
|
0.37%
3/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Inflam. and Immunologic Conditions
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thrombotic and Embolic Conditions
|
0.62%
5/801
|
0.00%
0/487
|
0.56%
1/178
|
|
Skin and subcutaneous tissue disorders
Apocrine and Eccrine Gland Disorders
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Skin and subcutaneous tissue disorders
Skin Neoplasms Benign
|
0.00%
0/801
|
0.00%
0/487
|
0.56%
1/178
|
|
Vascular disorders
Aortic Aneurysms and Dissections
|
0.25%
2/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Vascular disorders
Non-Site Specific Necrosis and Vascular Insufficiency NEC
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Vascular disorders
Peripheral Aneurysms and Dissections
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
|
Vascular disorders
Peripheral Embolism and Thrombosis
|
0.25%
2/801
|
0.00%
0/487
|
0.56%
1/178
|
|
Vascular disorders
Peripheral Vascular Disorders NEC
|
0.25%
2/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Vascular disorders
Peripheral Vasoconstriction, Necrosis and Vascular Insuff.
|
0.12%
1/801
|
0.00%
0/487
|
0.00%
0/178
|
|
Vascular disorders
Vascular Hypertensive Disorders NEC
|
0.25%
2/801
|
0.00%
0/487
|
0.56%
1/178
|
|
Vascular disorders
Vascular Hypotensive Disorders NEC
|
0.00%
0/801
|
0.21%
1/487
|
0.00%
0/178
|
Other adverse events
| Measure |
Febuxostat 80 mg QD
n=801 participants at risk
Febuxostat 80 mg, taken orally, once daily.
|
Febuxostat 120 mg QD
n=487 participants at risk
Febuxostat 120 mg, taken orally, once daily
|
Allopurinol QD
n=178 participants at risk
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (Excl Infective)
|
4.7%
38/801
|
6.8%
33/487
|
2.2%
4/178
|
|
General disorders
Oedema NEC
|
6.1%
49/801
|
3.5%
17/487
|
1.7%
3/178
|
|
Infections and infestations
Influenza Viral Infections
|
5.5%
44/801
|
3.3%
16/487
|
1.1%
2/178
|
|
Infections and infestations
Lower Respiratory Tract and Lung Infections
|
7.5%
60/801
|
5.5%
27/487
|
3.4%
6/178
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
30.7%
246/801
|
24.4%
119/487
|
16.9%
30/178
|
|
Musculoskeletal and connective tissue disorders
Joint Related Signs and Symptoms
|
12.5%
100/801
|
10.3%
50/487
|
6.7%
12/178
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissues Signs and Symptoms NEC
|
17.5%
140/801
|
16.8%
82/487
|
12.9%
23/178
|
|
Nervous system disorders
Headache NEC
|
5.6%
45/801
|
7.8%
38/487
|
3.9%
7/178
|
|
Skin and subcutaneous tissue disorders
Dermatitis and Eczema
|
5.5%
44/801
|
4.7%
23/487
|
1.1%
2/178
|
|
Vascular disorders
Vascular Hypertensive Disorders NEC
|
8.4%
67/801
|
8.4%
41/487
|
2.8%
5/178
|
Additional Information
Senior Vice President, 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