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Efficacy and Safety of Oral Febuxostat in Participants With Gout (CONFIRMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00430248
First received: January 25, 2007
Last updated: January 31, 2012
Last verified: January 2012
Results First Received: March 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gout
Interventions: Drug: Febuxostat
Drug: Allopurinol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 324 sites in the United States from 16 February 2007 to 12 March 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who were currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups.

Reporting Groups
  Description
Febuxostat 40 mg QD Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily for up to 6 months.
Allopurinol 200 mg or 300 mg QD Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.

Participant Flow:   Overall Study
    Febuxostat 40 mg QD   Febuxostat 80 mg QD   Allopurinol 200 mg or 300 mg QD
STARTED   757   756   756 
COMPLETED   632   598   621 
NOT COMPLETED   125   158   135 
Adverse Event                49                61                64 
Protocol Violation                10                2                4 
Personal Reasons                12                24                9 
Lost to Follow-up                28                33                28 
Therapeutic Failure                1                1                1 
Withdrawal by Subject                14                20                16 
Inclusion/Exclusion Criteria Not Met                0                2                0 
Gout Flare                3                7                2 
Reason Not Specified                8                8                11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Febuxostat 40 mg QD Febuxostat 40 mg, orally, once daily for up to 6 months.
Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily for up to 6 months.
Allopurinol 200 mg or 300 mg QD Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
Total Total of all reporting groups

Baseline Measures
   Febuxostat 40 mg QD   Febuxostat 80 mg QD   Allopurinol 200 mg or 300 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 757   756   756   2269 
Age, Customized 
[Units: Subjects]
       
<45 years of age   192   196   180   568 
45 to <65 years of age   450   432   445   1327 
≥65 years of age   115   128   131   374 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.5  (11.68)   53.0  (11.79)   52.9  (11.73)   52.8  (11.73) 
Gender 
[Units: Subjects]
       
Female   35   46   47   128 
Male   722   710   709   2141 
Ethnicity (NIH/OMB) 
[Units: Subjects]
       
Hispanic or Latino   47   49   53   149 
Not Hispanic or Latino   710   707   702   2119 
Unknown or Not Reported   0   0   1   1 
Race (NIH/OMB) 
[Units: Subjects]
       
American Indian or Alaska Native   6   10   6   22 
Asian   26   25   37   88 
Native Hawaiian or Other Pacific Islander   11   10   11   32 
Black or African American   83   78   67   228 
White   620   618   625   1863 
More than one race   11   15   8   34 
Unknown or Not Reported   0   0   2   2 
Body Mass Index 
[Units: Subjects]
       
<18.5 kilograms per meter² (kg/m²)   0   1   1   2 
18.5 kg/m² to <25 kg/m²   50   46   42   138 
25 kg/m² to <30 kg/m²   215   232   236   683 
≥30 kg/m²   490   476   476   1442 
Missing   2   1   1   4 
Cardiovascular Disease 
[Units: Subjects]
       
No   336   316   320   972 
Yes   421   440   436   1297 
Renal Function [1] 
[Units: Subjects]
       
Moderate Renal Impairment   130   136   136   402 
Mild Renal Impairment   349   367   365   1081 
Normal Renal Function   278   253   255   786 
[1]

Moderate renal impairment - baseline estimated creatinine clearance (CLcr) 30 milliliters per minute (mL/min) to 59 mL/min; Mild renal impairment - baseline estimated CLcr 60 mL/min to 89 mL/min; Normal renal function - estimated CLcr ≥90 mL/min.

CLcr calculated using the Cockroft-Gault formula corrected for ideal body weight.

Mean Body Mass Index 
[Units: Kg/m²]
Mean (Standard Deviation)
 32.9  (6.37)   32.9  (6.39)   32.7  (6.23)   32.8  (6.33) 
Serum Urate 
[Units: Milligrams per deciliter (mg/dL)]
Mean (Standard Deviation)
 9.6  (1.15)   9.6  (1.20)   9.5  (1.19)   9.6  (1.18) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.   [ Time Frame: Last Visit on treatment (up to 6 months) ]

2.  Secondary:   Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl   [ Time Frame: Last Visit on treatment (up to 6 months) ]

3.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.   [ Time Frame: Month 2 ]

4.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.   [ Time Frame: Month 4 ]

5.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.   [ Time Frame: Month 6 ]

6.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.   [ Time Frame: Month 2 ]

7.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.   [ Time Frame: Month 4 ]

8.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.   [ Time Frame: Month 6 ]

9.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.   [ Time Frame: Last Visit on treatment (up to 6 months) ]

10.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit   [ Time Frame: Month 2 ]

11.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit   [ Time Frame: Month 4 ]

12.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit   [ Time Frame: Month 6 ]

13.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit   [ Time Frame: Last Visit on treatment (up to 6 months) ]

14.  Secondary:   Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.   [ Time Frame: Baseline and Month 2 ]

15.  Secondary:   Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit   [ Time Frame: Baseline and Month 4 ]

16.  Secondary:   Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.   [ Time Frame: Baseline and Month 6 ]

17.  Secondary:   Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.   [ Time Frame: Baseline and Last Visit on treatment (up to 6 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Sciences
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00430248     History of Changes
Other Study ID Numbers: F-GT06-153
U1111-1114-0226 ( Registry Identifier: WHO )
Study First Received: January 25, 2007
Results First Received: March 12, 2009
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration