Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout (FACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00102440
Recruitment Status : Completed
First Posted : January 31, 2005
Results First Posted : July 16, 2009
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: Febuxostat
Drug: Allopurinol
Enrollment 760
Recruitment Details Subjects were enrolled at 112 investigative sites, 106 in the United States and 6 in Canada, from 11 July 2002 to 20 February 2004.
Pre-assignment Details Subjects currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollment in once daily (QD) treatment groups.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description Febuxostat 80 mg, orally, once daily for up to 52 weeks. Febuxostat 120 mg, orally, once daily for up to 52 weeks. Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Period Title: Overall Study
Started 256 251 253
Completed 168 153 187
Not Completed 88 98 66
Reason Not Completed
Lost to Follow-up             25             18             21
Adverse Event             16             23             8
Gout Flare             10             28             9
Personal Reason(s)             19             13             13
Other             11             14             14
Protocol Violation             7             2             1
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD Total
Hide Arm/Group Description Febuxostat 80 mg, orally, once daily for up to 52 weeks. Febuxostat 120 mg, orally, once daily for up to 52 weeks. Allopurinol 300 mg, orally, once daily for up to 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 256 251 253 760
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 256 participants 251 participants 253 participants 760 participants
<45 years 75 71 84 230
45 years to <65 years 140 133 125 398
≥65 years 41 47 44 132
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 256 participants 251 participants 253 participants 760 participants
51.8  (11.69) 52.0  (12.12) 51.6  (12.63) 51.8  (12.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 251 participants 253 participants 760 participants
Female
13
   5.1%
8
   3.2%
10
   4.0%
31
   4.1%
Male
243
  94.9%
243
  96.8%
243
  96.0%
729
  95.9%
Body Mass Index  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 256 participants 251 participants 253 participants 760 participants
<18.5 kilogram per meter² (kg/m²) 0 0 0 0
18.5 kg/m² to <25 kg/m² 15 12 7 34
25 kg/m² to <30 kg/m² 75 87 89 251
≥30 kg/m² 166 152 154 472
missing 0 0 3 3
Calculated Creatinine Clearance   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 256 participants 251 participants 253 participants 760 participants
<50 milliliters per minute (mL/min) 13 8 13 34
50 mL/min to <80 mL/min 77 90 68 235
80 mL/min to <120 mL/min 138 130 140 408
≥120 mL/min 28 23 29 80
missing 0 0 3 3
[1]
Measure Description: Calculated creatinine clearance based on the Cockcroft-Gault equation using ideal body weight.
Presence of Primary Palpable Tophus  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 256 participants 251 participants 253 participants 760 participants
Yes 52 53 46 151
No, but other tophi present 1 2 3 6
No and no other tophi present 203 196 204 603
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 256 participants 251 participants 253 participants 760 participants
White 193 199 195 587
Black or African American 24 20 18 62
Hispanic 22 17 19 58
Asian 10 9 6 25
Other 7 6 15 28
1.Primary Outcome
Title Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
Hide Description 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.
Time Frame Last 3 Visits (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 255 250 251
Measure Type: Number
Unit of Measure: Percentage of subjects
53 62 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is > -10%.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 32
Confidence Interval 97.5%
23.1 to 41.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is > -10%.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 41
Confidence Interval 97.5%
31.5 to 49.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit
Hide Description 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.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 186 159 199
Measure Type: Number
Unit of Measure: Percentage of subjects
72 82 42
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 159 145 178
Measure Type: Number
Unit of Measure: Percentage of subjects
81 82 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.883
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit
Hide Description 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.
Time Frame Final Visit (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 249 242 242
Measure Type: Number
Unit of Measure: Percentage of subjects
74 80 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Serum Urate Levels at Week 28.
Hide Description 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.
Time Frame Baseline and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 186 159 199
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-46.3  (15.76) -53.5  (18.20) -34.8  (12.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in Serum Urate Levels at Week 52.
Hide Description 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.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 159 145 178
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-47.7  (17.50) -53.0  (19.31) -34.8  (13.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline in Serum Urate Levels at Final Visit
Hide Description 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.
Time Frame Baseline and Final Visit (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 249 242 242
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-44.7  (19.10) -51.5  (19.91) -33.0  (15.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Hide Description 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.
Time Frame Baseline and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 36 28 33
Median (Inter-Quartile Range)
Unit of Measure: percent change from baseline
-29.5
(-66.0 to 4.1)
-49.5
(-80.0 to -34.9)
-28.6
(-54.9 to 0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Hide Description 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.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 32 26 30
Median (Inter-Quartile Range)
Unit of Measure: percent change from baseline
-83.4
(-100 to -15.6)
-65.5
(-85.5 to -38.9)
-49.7
(-96.0 to 0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.619
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Hide Description 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.
Time Frame Baseline and Final Visit (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 50 51 44
Median (Inter-Quartile Range)
Unit of Measure: percent change from baseline
-51.7
(-100 to -8.3)
-43.8
(-83.0 to 0.0)
-39.6
(-65.0 to 1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.372
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.
Hide Description 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.
Time Frame Baseline and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 38 30 37
Median (Inter-Quartile Range)
Unit of Measure: number of tophi
0.0
(0.0 to 0.0)
0.0
(-1.0 to 0.0)
0.0
(0.0 to 0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.674
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.411
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.
Hide Description 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.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 33 28 35
Median (Inter-Quartile Range)
Unit of Measure: number of tophi
0.0
(-1.0 to 0.0)
-1.0
(-1.0 to 0.0)
0.0
(-1.0 to 0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.362
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.
Hide Description 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.
Time Frame Baseline and Final Visit (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 52 53 47
Median (Inter-Quartile Range)
Unit of Measure: number of tophi
0.0
(-1.0 to 0.0)
0.0
(-1.0 to 0.0)
0.0
(-1.0 to 0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.657
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.719
Comments P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.
Hide Description 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.
Time Frame Weeks 8 through 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 52.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description:
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinol 300 mg, orally, once daily for up to 52 weeks.
Overall Number of Participants Analyzed 228 215 234
Measure Type: Number
Unit of Measure: percentage of subjects
64 70 64
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Allopurinol 300 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Febuxostat 120 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.266
Comments Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Hide Arm/Group Description Febuxostat 80 mg, orally, once daily for up to 52 weeks. Febuxostat 120 mg, orally, once daily for up to 52 weeks. Allopurinol 300 mg, orally, once daily for up to 52 weeks.
All-Cause Mortality
Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/256 (3.91%)   19/251 (7.57%)   18/253 (7.11%) 
Cardiac disorders       
Cardiac Disorders not elsewhere classified (NEC)  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Coronary Artery Disorders NEC  1  0/256 (0.00%)  0/251 (0.00%)  4/253 (1.58%) 
Heart Failures NEC  1  3/256 (1.17%)  1/251 (0.40%)  0/253 (0.00%) 
Ischaemic Coronary Artery Disorders NEC  1  3/256 (1.17%)  2/251 (0.80%)  2/253 (0.79%) 
Rate and Rhythm Disorders NEC  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Supraventricular Arrhythmias  1  1/256 (0.39%)  1/251 (0.40%)  0/253 (0.00%) 
Ventricular Arrhythmias and Cardiac Arrest  1  0/256 (0.00%)  2/251 (0.80%)  1/253 (0.40%) 
Gastrointestinal disorders       
Acute and Chronic Pancreatitis  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Gastrointestinal Fistulae  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Gastrointestinal Ulcers and Perforation, Site Unspecified  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Intestinal Haemorrhages  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Intestinal Ulcers and Perforation NEC  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Peritoneal and Retroperitoneal Haemorrhages  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Umbilical Hernias  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
General disorders       
Febrile Disorders  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Immune system disorders       
Allergies to Food, Food Additives, Drugs and Other Chemicals  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Infections and infestations       
Abdominal and Gastrointestinal Infections  1  0/256 (0.00%)  1/251 (0.40%)  2/253 (0.79%) 
Infections NEC  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Lower Respiratory Tract and Lung Infections  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Skin Structures and Soft Tissue Infections  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Staphylococcal Infections  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Urinary Tract Infections  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Viral Infections NEC  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Injury, poisoning and procedural complications       
Chest and Lung Injuries NEC  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Non-Site Specific Injuries NEC  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Site Specific Injuries NEC  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Investigations       
Coagulation and Bleeding Analyses  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Musculoskeletal and connective tissue disorders       
Joint Related Signs and Symptoms  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Musculoskeletal and Connective Tissue Signs and Symptoms NEC  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Osteoarthropathies  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Spine and Neck Deformities  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colonic Neoplasms Malignant  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Prostatic Neoplasms Malignant  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Testicular Neoplasms Malignant  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Nervous system disorders       
Central Nervous System Vascular Disorders NEC  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Central nervous system Hemorrhages & Cerebrovascular Accidents  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Cervical Spinal Cord and Nerve Root Disorders  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Disturbances in Consciousness NEC  1  0/256 (0.00%)  1/251 (0.40%)  1/253 (0.40%) 
Encephalopathies NEC  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Renal and urinary disorders       
Renal Failure and Impairment  1  2/256 (0.78%)  0/251 (0.00%)  0/253 (0.00%) 
Renal Lithiasis  1  0/256 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Respiratory, thoracic and mediastinal disorders       
Bronchospasm and Obstruction  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Pneumothorax and Pleural Effusions NEC  1  1/256 (0.39%)  0/251 (0.00%)  0/253 (0.00%) 
Pulmonary Thrombotic and Embolic Conditions  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Respiratory Failures (Excluding [Excl] Neonatal)  1  1/256 (0.39%)  1/251 (0.40%)  0/253 (0.00%) 
Vascular disorders       
Peripheral Embolism and Thrombosis  1  0/256 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 300 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   164/256 (64.06%)   145/251 (57.77%)   167/253 (66.01%) 
Gastrointestinal disorders       
Diarrhoea (Excl Infective)  1  27/256 (10.55%)  25/251 (9.96%)  16/253 (6.32%) 
Nausea and Vomiting Symptoms  1  19/256 (7.42%)  13/251 (5.18%)  8/253 (3.16%) 
General disorders       
Oedema NEC  1  18/256 (7.03%)  8/251 (3.19%)  8/253 (3.16%) 
Infections and infestations       
Influenza Viral Infections  1  12/256 (4.69%)  13/251 (5.18%)  12/253 (4.74%) 
Lower Respiratory Tract and Lung Infections  1  13/256 (5.08%)  7/251 (2.79%)  8/253 (3.16%) 
Upper Respiratory Tract Infections  1  77/256 (30.08%)  53/251 (21.12%)  72/253 (28.46%) 
Injury, poisoning and procedural complications       
Limb Injuries NEC (Including [Incl] Traumatic Amputation)  1  12/256 (4.69%)  10/251 (3.98%)  11/253 (4.35%) 
Non-Site Specific Injuries NEC  1  11/256 (4.30%)  10/251 (3.98%)  12/253 (4.74%) 
Investigations       
Liver Function Analyses  1  13/256 (5.08%)  16/251 (6.37%)  12/253 (4.74%) 
Musculoskeletal and connective tissue disorders       
Joint Related Signs and Symptoms  1  39/256 (15.23%)  32/251 (12.75%)  37/253 (14.62%) 
Musculoskeletal and Connective Tissue Signs and Symptoms NEC  1  35/256 (13.67%)  38/251 (15.14%)  37/253 (14.62%) 
Nervous system disorders       
Headache NEC  1  23/256 (8.98%)  23/251 (9.16%)  22/253 (8.70%) 
Neurological Signs and Symptoms NEC  1  17/256 (6.64%)  9/251 (3.59%)  7/253 (2.77%) 
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Tract Signs and Symptoms  1  13/256 (5.08%)  10/251 (3.98%)  17/253 (6.72%) 
Vascular disorders       
Vascular Hypertensive Disorders NEC  1  7/256 (2.73%)  10/251 (3.98%)  14/253 (5.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research & Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00102440     History of Changes
Other Study ID Numbers: C02-010
U1111-1114-0184 ( Registry Identifier: WHO )
First Submitted: January 29, 2005
First Posted: January 31, 2005
Results First Submitted: March 12, 2009
Results First Posted: July 16, 2009
Last Update Posted: February 2, 2012