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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00174967
First received: September 9, 2005
Last updated: July 27, 2011
Last verified: July 2011
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: Diagnostic
Condition: Gout
Interventions: Drug: Placebo
Drug: Febuxostat

  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 24 investigative sites from 31 January 2001 to 9 July 2001

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Febuxostat 40 mg QD Febuxostat 40 mg, orally, once daily.
Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg QD Febuxostat 120 mg, orally, once daily.
Placebo QD Placebo, orally, once daily

Participant Flow:   Overall Study
    Febuxostat 40 mg QD     Febuxostat 80 mg QD     Febuxostat 120 mg QD     Placebo QD  
STARTED     37     40     38     38  
COMPLETED     36     37     36     36  
NOT COMPLETED     1     3     2     2  
Adverse Event                 1                 2                 2                 1  
Gout Flare                 0                 0                 0                 1  
Not Specified                 0                 1                 0                 0  



  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.
Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily.
Febuxostat 120 mg QD Febuxostat 120 mg, orally, once daily.
Placebo QD Placebo, orally, once daily
Total Total of all reporting groups

Baseline Measures
    Febuxostat 40 mg QD     Febuxostat 80 mg QD     Febuxostat 120 mg QD     Placebo QD     Total  
Number of Participants  
[units: participants]
  37     40     38     38     153  
Age  
[units: years]
Mean ± Standard Deviation
  52.2  ± 14.04     55.2  ± 13.09     56.2  ± 10.83     52.4  ± 12.63     54.0  ± 12.69  
Age, Customized  
[units: 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  
Gender  
[units: participants]
         
Female     4     2     5     6     17  
Male     33     38     33     32     136  
Race/Ethnicity, Customized  
[units: 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  
[units: 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  



  Outcome Measures
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1.  Primary:   Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.   [ Time Frame: Day 28. ]

2.  Secondary:   Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.   [ Time Frame: Day 7. ]

3.  Secondary:   Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.   [ Time Frame: Day 14. ]

4.  Secondary:   Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.   [ Time Frame: Day 21. ]

5.  Secondary:   Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.   [ Time Frame: Baseline and Day 7. ]

6.  Secondary:   Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.   [ Time Frame: Baseline and Day 14. ]

7.  Secondary:   Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit   [ Time Frame: Baseline and Day 21. ]

8.  Secondary:   Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.   [ Time Frame: Baseline and Day 28. ]

9.  Secondary:   Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.   [ Time Frame: Baseline and Any visit (Day 7, 14, 21,or 28) ]

10.  Secondary:   Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.   [ Time Frame: Baseline and Day 28. ]


  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 Science
Organization: Takeda Global Research & Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:

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
Study First Received: September 9, 2005
Results First Received: March 12, 2009
Last Updated: July 27, 2011
Health Authority: United States: Food and Drug Administration