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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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  
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: milligramsĀ perĀ deciliterĀ (mg/dL)]
Mean ± Standard Deviation
  9.6  ± 1.15     9.6  ± 1.20     9.5  ± 1.19     9.6  ± 1.18  
[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.




  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


  More Information
  Hide More Information

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.


Limitations and Caveats
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
No text entered.  


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:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00430248     History of Changes
Other Study ID Numbers: F-GT06-153, U1111-1114-0226
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