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Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout

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: NCT00174967
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2009
Last Update Posted : July 29, 2011
Sponsor:
Information provided by:
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Gout
Interventions Drug: Placebo
Drug: Febuxostat
Enrollment 153
Recruitment Details Subjects were enrolled at 24 investigative sites from 31 January 2001 to 9 July 2001
Pre-assignment Details Participants currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups. All other subjects also initiated prophylactic medications.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description Febuxostat 40 mg, orally, once daily. Febuxostat 80 mg, orally, once daily. Febuxostat 120 mg, orally, once daily. Placebo, orally, once daily
Period Title: Overall Study
Started 37 40 38 38
Completed 36 37 36 36
Not Completed 1 3 2 2
Reason Not Completed
Adverse Event             1             2             2             1
Gout Flare             0             0             0             1
Not Specified             0             1             0             0
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD Total
Hide Arm/Group Description Febuxostat 40 mg, orally, once daily. Febuxostat 80 mg, orally, once daily. Febuxostat 120 mg, orally, once daily. Placebo, orally, once daily Total of all reporting groups
Overall Number of Baseline Participants 37 40 38 38 153
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 40 participants 38 participants 38 participants 153 participants
52.2  (14.04) 55.2  (13.09) 56.2  (10.83) 52.4  (12.63) 54.0  (12.69)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 38 participants 38 participants 153 participants
<45 years 8 10 7 12 37
45 years to <65 years 21 19 23 17 80
≥65 years 8 11 8 9 36
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 38 participants 38 participants 153 participants
Female
4
  10.8%
2
   5.0%
5
  13.2%
6
  15.8%
17
  11.1%
Male
33
  89.2%
38
  95.0%
33
  86.8%
32
  84.2%
136
  88.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 38 participants 38 participants 153 participants
White 32 35 34 32 133
Black or African American 3 3 2 3 11
Hispanic 1 1 1 1 4
Asian 0 1 1 0 2
Other 1 0 0 2 3
Body Mass Index  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 38 participants 38 participants 153 participants
≤25 kilogram per meter² (kg/m²) 2 3 3 0 8
>25 kg/m² to 30 kg/m² 12 12 14 13 51
>30 kg/m² to 35 kg/m² 16 12 12 16 56
>35 kg/m² to 40 kg/m² 4 7 5 6 22
>40 kg/m² 3 6 3 3 15
missing 0 0 1 0 1
1.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.
Hide Description Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 28 visit was summarized.
Time Frame Day 28.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on intent-to-treat (ITT) subjects, defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no postbaseline visits were available.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Measure Type: Number
Unit of Measure: percentage of subjects
56 76 94 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.
Hide Description Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized.
Time Frame Day 7.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Measure Type: Number
Unit of Measure: percentage of subjects
50 59 91 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.
Hide Description Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized.
Time Frame Day 14.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Measure Type: Number
Unit of Measure: percentage of subjects
56 68 94 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.
Hide Description Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized.
Time Frame Day 21.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Measure Type: Number
Unit of Measure: percentage of subjects
59 76 97 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.
Hide Description Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.
Time Frame Baseline and Day 7.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-35.0  (9.67) -39.2  (15.9) -53.44  (12.3) 0.71  (12.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.
Hide Description Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.
Time Frame Baseline and Day 14.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-37.1  (11.70) -41.8  (14.63) -56.9  (8.36) 1.62  (10.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit
Hide Description Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.
Time Frame Baseline and Day 21.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-37.3  (11.30) -43.9  (16.3) -59.4  (7.58) -0.57  (10.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.
Hide Description Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.
Time Frame Baseline and Day 28.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-36.6  (12.07) -44.3  (17.53) -59.1  (9.92) -2.2  (12.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.
Hide Description Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.
Time Frame Baseline and Any visit (Day 7, 14, 21,or 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 34 37 34 35
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
42.5  (10.04) 49.2  (13.24) 62.8  (7.05) 10.0  (11.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.
Hide Description 24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.
Time Frame Baseline and Day 28.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. Missing data was not imputed
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg, orally, once daily.
Placebo, orally, once daily
Overall Number of Participants Analyzed 33 35 34 34
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-43.6  (28.9) -46.5  (27.0) -45.7  (30.1) 5.9  (37.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat 40 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Febuxostat 80 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat 120 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Hide Arm/Group Description Febuxostat 40 mg, orally, once daily. Febuxostat 80 mg, orally, once daily. Febuxostat 120 mg, orally, once daily. Placebo, orally, once daily
All-Cause Mortality
Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   1/40 (2.50%)   2/38 (5.26%)   0/38 (0.00%) 
General disorders         
Back Pain  1  0/37 (0.00%)  0/40 (0.00%)  1/38 (2.63%)  0/38 (0.00%) 
Nervous system disorders         
Delirium  1  0/37 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  0/38 (0.00%) 
Guillian Barre Syndrome  1  0/37 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  0/38 (0.00%) 
Psychiatric disorders         
Suicide Attempt  1  0/37 (0.00%)  0/40 (0.00%)  1/38 (2.63%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia  1  0/37 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/37 (48.65%)   19/40 (47.50%)   16/38 (42.11%)   17/38 (44.74%) 
Gastrointestinal disorders         
Diarrhoea  1  1/37 (2.70%)  8/40 (20.00%)  4/38 (10.53%)  4/38 (10.53%) 
Dyspepsia  1  1/37 (2.70%)  2/40 (5.00%)  0/38 (0.00%)  0/38 (0.00%) 
Increased Appetite  1  2/37 (5.41%)  0/40 (0.00%)  0/38 (0.00%)  0/38 (0.00%) 
General disorders         
Abdominal Pain  1  1/37 (2.70%)  1/40 (2.50%)  2/38 (5.26%)  3/38 (7.89%) 
Back Pain  1  3/37 (8.11%)  2/40 (5.00%)  2/38 (5.26%)  1/38 (2.63%) 
Flu Syndrome  1  1/37 (2.70%)  0/40 (0.00%)  1/38 (2.63%)  2/38 (5.26%) 
Pain  1  6/37 (16.22%)  3/40 (7.50%)  2/38 (5.26%)  4/38 (10.53%) 
Infections and infestations         
Infection  1  1/37 (2.70%)  0/40 (0.00%)  1/38 (2.63%)  2/38 (5.26%) 
Injury, poisoning and procedural complications         
Accidental Injury  1  0/37 (0.00%)  2/40 (5.00%)  1/38 (2.63%)  0/38 (0.00%) 
Investigations         
Liver Function Tests Abnormal  1  2/37 (5.41%)  1/40 (2.50%)  1/38 (2.63%)  1/38 (2.63%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/37 (5.41%)  1/40 (2.50%)  2/38 (5.26%)  0/38 (0.00%) 
Myalgia  1  1/37 (2.70%)  1/40 (2.50%)  2/38 (5.26%)  2/38 (5.26%) 
Nervous system disorders         
Headache  1  3/37 (8.11%)  2/40 (5.00%)  2/38 (5.26%)  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders         
Pharyngitis  1  0/37 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  2/38 (5.26%) 
Skin and subcutaneous tissue disorders         
Rash  1  0/37 (0.00%)  1/40 (2.50%)  3/38 (7.89%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
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: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00174967     History of Changes
Other Study ID Numbers: TMX-00-004
U1111-1114-1992 ( Registry Identifier: WHO )
First Submitted: September 9, 2005
First Posted: September 15, 2005
Results First Submitted: March 12, 2009
Results First Posted: July 16, 2009
Last Update Posted: July 29, 2011