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Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010 (EXCEL)

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ClinicalTrials.gov Identifier: NCT00175019
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : September 7, 2009
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: Febuxostat
Drug: Allopurinol
Enrollment 1086
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description Febuxostat 80 mg, taken orally, once daily. Febuxostat 120 mg, taken orally, once daily Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Period Title: Overall Study
Started 606 [1] 388 [1] 92 [1]
Completed 412 [1] 217 [1] 35 [1]
Not Completed 194 171 57
Reason Not Completed
Adverse Event             54             22             2
Protocol Violation             6             3             3
Lost to Follow-up             42             39             9
Did not continue under Amendment 4             1             1             2
Personal Reason(s)             39             31             8
Therapeutic Failure             10             38             22
Gout Flare             2             3             0
Reason Not Specified             40             34             11
[1]
Based on final stable treatment in C02-021, defined as after dose switch not allowed.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD Total
Hide Arm/Group Description Febuxostat 80 mg, taken orally, once daily. Febuxostat 120 mg, taken orally, once daily Allopurinol 100 mg or 300 mg, tablets, orally, once daily. Total of all reporting groups
Overall Number of Baseline Participants 606 388 92 1086
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 606 participants 388 participants 92 participants 1086 participants
53.0  (11.74) 48.4  (11.02) 51.3  (12.72) 51.2  (11.76)
[1]
Measure Description: Based on Final Stable Treatment in study C02-021
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 606 participants 388 participants 92 participants 1086 participants
Female
25
   4.1%
17
   4.4%
2
   2.2%
44
   4.1%
Male
581
  95.9%
371
  95.6%
90
  97.8%
1042
  95.9%
[1]
Measure Description: Based on Final Stable Treatment in study C02-021
Presence of Tophus   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 606 participants 388 participants 92 participants 1086 participants
Present 116 83 15 214
Absent 490 305 77 872
[1]
Measure Description: Based on Final Stable Treatment in study C02-021
Race/Ethnicity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 606 participants 388 participants 92 participants 1086 participants
Asian 15 9 4 28
Black or African American 47 33 16 96
White 499 299 64 862
Hispanic 30 29 7 66
Other 15 18 1 34
[1]
Measure Description: Based on Final Stable Treatment in study C02-021
Renal Function   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 606 participants 388 participants 92 participants 1086 participants
Normal 593 381 92 1066
Impaired 13 7 0 20
[1]
Measure Description: Based on Final Stable Treatment in study C02-021. Impaired defined as serum creatinine <1.5 mg/dL.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 606 participants 388 participants 92 participants 1086 participants
31.9  (5.49) 34.1  (6.71) 32.4  (5.58) 31.9  (5.49)
[1]
Measure Description: Based on Final Stable Treatment in study C02-021
Serum Urate   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 606 participants 388 participants 92 participants 1086 participants
9.65  (1.20) 10.05  (1.29) 9.83  (1.27) 9.81  (1.25)
[1]
Measure Description: Based on Final Stable Treatment in study C02-021
1.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.
Hide Description 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.
Time Frame Month 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 620 277 139
Measure Type: Number
Unit of Measure: percentage of subjects
80.8 87.0 46.0
2.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.
Hide Description 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.
Time Frame Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 422 168 45
Measure Type: Number
Unit of Measure: percentage of subjects
88.9 86.3 82.2
3.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.
Hide Description 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.
Time Frame Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 364 141 42
Measure Type: Number
Unit of Measure: percentage of subjects
89.3 87.2 78.6
4.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.
Hide Description 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.
Time Frame Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 120 47 10
Measure Type: Number
Unit of Measure: percentage of subjects
90.8 91.5 90.0
5.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.
Hide Description 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.
Time Frame Last Visit on treatment (up to 40 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 636 283 141
Measure Type: Number
Unit of Measure: percentage of subjects
70.8 82.0 32.6
6.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment.
Hide Description 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.
Time Frame Last Visit on treatment (up to 40 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 636 283 141
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-46.69  (17.43) -52.99  (19.12) -32.17  (17.71)
7.Secondary Outcome
Title Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline.
Hide Description 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.
Time Frame Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 80 51 9
Median (Inter-Quartile Range)
Unit of Measure: percent change from baseline
-82
(-100 to -40)
-79
(-100 to -26)
-56
(-100 to -16)
8.Secondary Outcome
Title Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline.
Hide Description 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.
Time Frame Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 64 32 4
Median (Inter-Quartile Range)
Unit of Measure: percent change from baseline
-100
(-100 to -54)
-96
(-100 to -52)
-87
(-98 to -29)
9.Secondary Outcome
Title Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline.
Hide Description 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.
Time Frame Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 1 0 0
Median (Inter-Quartile Range)
Unit of Measure: percent change from baseline
-83
(-83 to -83)
10.Secondary Outcome
Title Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline.
Hide Description 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.
Time Frame Final Visit (up to 40 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 107 76 14
Median (Inter-Quartile Range)
Unit of Measure: percent change from baseline
-96
(-100 to -42)
-84
(-100 to -16)
-67
(-100 to 0)
11.Secondary Outcome
Title Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit.
Hide Description 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.
Time Frame Final Visit (up to 40 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 107 76 14
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-59.9  (45.9) -58.3  (42.5) -48.7  (42.5)
12.Secondary Outcome
Title Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12.
Hide Description The percentage of subjects requiring treatment for gout flare during the first twelve months of final stable treatment was summarized.
Time Frame Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 606 388 92
Measure Type: Number
Unit of Measure: percentage of subjects
29.4 42.5 28.3
13.Secondary Outcome
Title Percentage of Subjects Requiring Treatment for Gout Flare After Month 12.
Hide Description The percentage of subjects requiring treatment for gout flare after the first 12 months of final stable treatment was summarized.
Time Frame After Month 12 to Final Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description:
Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg, taken orally, once daily
Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Overall Number of Participants Analyzed 516 293 56
Measure Type: Number
Unit of Measure: percentage of subjects
15.3 19.8 23.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol QD
Hide Arm/Group Description Febuxostat 80 mg, taken orally, once daily. Febuxostat 120 mg, taken orally, once daily Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
All-Cause Mortality
Febuxostat 80 mg QD Febuxostat 120 mg QD Allopurinol 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 QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   98/801 (12.23%)   50/487 (10.27%)   16/178 (8.99%) 
Blood and lymphatic system disorders       
Anaemia Deficiencies  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Thrombocytopenias  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Cardiac disorders       
Aortic Valvular Disorders  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Cardiac Conduction Disorders  1  2/801 (0.25%)  0/487 (0.00%)  0/178 (0.00%) 
Cardiomyopathies  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Coronary Artery Disorders not elsewhere classified (NEC)  1  13/801 (1.62%)  6/487 (1.23%)  1/178 (0.56%) 
Heart Failures NEC  1  3/801 (0.37%)  3/487 (0.62%)  1/178 (0.56%) 
Ischaemic Coronary Artery Disorders  1  17/801 (2.12%)  3/487 (0.62%)  2/178 (1.12%) 
Myocardial Disorders NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Supraventricular Arrhythmias  1  1/801 (0.12%)  2/487 (0.41%)  1/178 (0.56%) 
Ventricular Arrhythmias and Cardiac Arrest  1  2/801 (0.25%)  0/487 (0.00%)  0/178 (0.00%) 
Congenital, familial and genetic disorders       
Male Reproductive Tract Disorders Congenital  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Ear and labyrinth disorders       
Hearing Losses  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Inner Ear Signs and Symptoms  1  0/801 (0.00%)  2/487 (0.41%)  0/178 (0.00%) 
Gastrointestinal disorders       
Abdominal Hernias, Site Unspecified  1  0/801 (0.00%)  2/487 (0.41%)  0/178 (0.00%) 
Benign Neoplasms GastrointestinaI (Excluding Oral Cavity)  1  1/801 (0.12%)  2/487 (0.41%)  0/178 (0.00%) 
Colitis (Excluding Infective)  1  1/801 (0.12%)  1/487 (0.21%)  0/178 (0.00%) 
Diaphragmatic Hernias  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Duodenal and Small Intestinal Stenosis and Obstruction  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Gastrointestinal Atonic and Hypomotility Disorders NEC  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Gastrointestinal Stenosis and Obstruction NEC  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Inguinal Hernias  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Intestinal Ulcers and Perforation NEC  1  0/801 (0.00%)  0/487 (0.00%)  1/178 (0.56%) 
Umbilical Hernias  1  0/801 (0.00%)  0/487 (0.00%)  1/178 (0.56%) 
General disorders       
Gastrointestinal Disorders NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Hernias NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Pain and Discomfort NEC  1  1/801 (0.12%)  2/487 (0.41%)  0/178 (0.00%) 
Hepatobiliary disorders       
Bile Duct Infections and Inflammations  1  0/801 (0.00%)  0/487 (0.00%)  1/178 (0.56%) 
Cholecystitis and Cholelithiasis  1  7/801 (0.87%)  1/487 (0.21%)  1/178 (0.56%) 
Hepatocellular Damage and Hepatitis NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Infections and infestations       
Abdominal and Gastrointestinal Infections  1  3/801 (0.37%)  2/487 (0.41%)  2/178 (1.12%) 
Bacterial Infections NEC  1  3/801 (0.37%)  1/487 (0.21%)  0/178 (0.00%) 
Bone and Joint Infections  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Cardiac Infections  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Infections NEC  1  5/801 (0.62%)  0/487 (0.00%)  0/178 (0.00%) 
Lower Respiratory Tract and Lung Infections  1  7/801 (0.87%)  2/487 (0.41%)  0/178 (0.00%) 
Sepsis, Bacteraemia, Viraemia, and Fungaemia NEC  1  3/801 (0.37%)  0/487 (0.00%)  0/178 (0.00%) 
Staphylococcal Infections  1  2/801 (0.25%)  0/487 (0.00%)  0/178 (0.00%) 
Upper Respiratory Tract Infections  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Urinary Tract Infections  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Injury, poisoning and procedural complications       
Cardiac and Vascular Procedural Complications  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Cerebral Injuries NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Limb Injuries NEC (Including Traumatic Amputation)  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Lower limb Fractures and Dislocations  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Muscle, Tendon and Ligament Injuries  1  1/801 (0.12%)  1/487 (0.21%)  0/178 (0.00%) 
Non-Site Specific Injuries NEC  1  4/801 (0.50%)  0/487 (0.00%)  0/178 (0.00%) 
Non-Site Specific Procedural Complications  1  4/801 (0.50%)  0/487 (0.00%)  0/178 (0.00%) 
Investigations       
Neurologic Diagnostic Procedures  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Metabolism and nutrition disorders       
Diabetes Mellitus (Including Subtypes)  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
General Nutritional Disorders NEC  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Magnesium Metabolism Disorders  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Potassium Imbalance  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Musculoskeletal and connective tissue disorders       
Bone Disorders NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Intervertebral Disc Disorders  1  0/801 (0.00%)  2/487 (0.41%)  1/178 (0.56%) 
Joint Related Disorders NEC  1  2/801 (0.25%)  1/487 (0.21%)  0/178 (0.00%) 
Muscle Related Signs and Symptoms NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Osteoarthropathies  1  3/801 (0.37%)  4/487 (0.82%)  0/178 (0.00%) 
Spine and Neck Deformities  1  1/801 (0.12%)  0/487 (0.00%)  2/178 (1.12%) 
Colonic Neoplasms Malignant  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
B-cell Lymphomas NEC  1  2/801 (0.25%)  0/487 (0.00%)  0/178 (0.00%) 
Bile Duct Neoplasms Malignant  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Breast and Nipple Neoplasms Malignant  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Endocrine Neoplasms Benign NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Neoplasms Benign Site Unspecified NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Non-Small Cell Malignant/Respiratory Tract Cell Type Specified  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Oesophageal Neoplasms Malignant  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Ovarian Neoplasms Benign  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Pancreatic Neoplasms Malignant (Excl Islet Cell and Carcinoid)  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Prostatic Neoplasms Malignant  1  2/801 (0.25%)  2/487 (0.41%)  0/178 (0.00%) 
Renal Cell Carcinoma  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Nervous system disorders       
Central Nervous System Haemorrhages and CVA  1  6/801 (0.75%)  2/487 (0.41%)  0/178 (0.00%) 
Central Nervous System Vascular Disorders NEC  1  2/801 (0.25%)  1/487 (0.21%)  0/178 (0.00%) 
Cervical Spinal Cord and Nerve Root Disorders  1  0/801 (0.00%)  0/487 (0.00%)  1/178 (0.56%) 
Disturbances in Consciousness NEC  1  2/801 (0.25%)  2/487 (0.41%)  0/178 (0.00%) 
Neurologic Visual Problems NEC  1  0/801 (0.00%)  0/487 (0.00%)  1/178 (0.56%) 
Neurological Signs and Symptoms NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Paralysis and Paresis (Excl Cranial Nerve)  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Transient Cerebrovascular Events  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Psychiatric disorders       
Renal Vascular and Ischaemic Conditions  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Renal and urinary disorders       
Renal Failure and Impairment  1  3/801 (0.37%)  0/487 (0.00%)  0/178 (0.00%) 
Renal Lithiasis  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Breathing Abnormalities  1  2/801 (0.25%)  0/487 (0.00%)  0/178 (0.00%) 
Bronchospasms and Obstruction  1  3/801 (0.37%)  1/487 (0.21%)  0/178 (0.00%) 
Lower Respiratory Tract Inflam. and Immunologic Conditions  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Pulmonary Thrombotic and Embolic Conditions  1  5/801 (0.62%)  0/487 (0.00%)  1/178 (0.56%) 
Skin and subcutaneous tissue disorders       
Apocrine and Eccrine Gland Disorders  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Skin Neoplasms Benign  1  0/801 (0.00%)  0/487 (0.00%)  1/178 (0.56%) 
Vascular disorders       
Aortic Aneurysms and Dissections  1  2/801 (0.25%)  1/487 (0.21%)  0/178 (0.00%) 
Non-Site Specific Necrosis and Vascular Insufficiency NEC  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Peripheral Aneurysms and Dissections  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Peripheral Embolism and Thrombosis  1  2/801 (0.25%)  0/487 (0.00%)  1/178 (0.56%) 
Peripheral Vascular Disorders NEC  1  2/801 (0.25%)  0/487 (0.00%)  0/178 (0.00%) 
Peripheral Vasoconstriction, Necrosis and Vascular Insuff.  1  1/801 (0.12%)  0/487 (0.00%)  0/178 (0.00%) 
Vascular Hypertensive Disorders NEC  1  2/801 (0.25%)  0/487 (0.00%)  1/178 (0.56%) 
Vascular Hypotensive Disorders NEC  1  0/801 (0.00%)  1/487 (0.21%)  0/178 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
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 QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   444/801 (55.43%)   257/487 (52.77%)   66/178 (37.08%) 
Gastrointestinal disorders       
Diarrhoea (Excl Infective)  1  38/801 (4.74%)  33/487 (6.78%)  4/178 (2.25%) 
General disorders       
Oedema NEC  1  49/801 (6.12%)  17/487 (3.49%)  3/178 (1.69%) 
Infections and infestations       
Influenza Viral Infections  1  44/801 (5.49%)  16/487 (3.29%)  2/178 (1.12%) 
Lower Respiratory Tract and Lung Infections  1  60/801 (7.49%)  27/487 (5.54%)  6/178 (3.37%) 
Upper Respiratory Tract Infections  1  246/801 (30.71%)  119/487 (24.44%)  30/178 (16.85%) 
Musculoskeletal and connective tissue disorders       
Joint Related Signs and Symptoms  1  100/801 (12.48%)  50/487 (10.27%)  12/178 (6.74%) 
Musculoskeletal and Connective Tissues Signs and Symptoms NEC  1  140/801 (17.48%)  82/487 (16.84%)  23/178 (12.92%) 
Nervous system disorders       
Headache NEC  1  45/801 (5.62%)  38/487 (7.80%)  7/178 (3.93%) 
Skin and subcutaneous tissue disorders       
Dermatitis and Eczema  1  44/801 (5.49%)  23/487 (4.72%)  2/178 (1.12%) 
Vascular disorders       
Vascular Hypertensive Disorders NEC  1  67/801 (8.36%)  41/487 (8.42%)  5/178 (2.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Subjects may receive >1 treatment. Adverse events are summarized by treatment at time of observation and subjects who receive >1 treatment are summarized for each treatment they receive, so subjects at risk will not match number of participants.
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: Senior Vice President, Clinical Science
Organization: Takeda Global Research & Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00175019     History of Changes
Other Study ID Numbers: C02-021
U1111-1113-9814 ( Registry Identifier: WHO )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: March 12, 2009
Results First Posted: September 7, 2009
Last Update Posted: July 27, 2010