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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00175019
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010
Results First Received: March 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   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 174 investigative sites, including 168 in the United States and 6 in Canada, from 28 July 2003 to 26 February 2007.

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

Reporting Groups
  Description
Febuxostat 80 mg QD Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg QD Febuxostat 120 mg, taken orally, once daily
Allopurinol QD Allopurinol 100 mg or 300 mg, tablets, orally, once daily.

Participant Flow:   Overall Study
    Febuxostat 80 mg QD     Febuxostat 120 mg QD     Allopurinol QD  
STARTED     606 [1]   388 [1]   92 [1]
COMPLETED     412 [1]   217 [1]   35 [1]
NOT COMPLETED     194     171     57  
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.



  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 80 mg QD Febuxostat 80 mg, taken orally, once daily.
Febuxostat 120 mg QD Febuxostat 120 mg, taken orally, once daily
Allopurinol QD Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Total Total of all reporting groups

Baseline Measures
    Febuxostat 80 mg QD     Febuxostat 120 mg QD     Allopurinol QD     Total  
Number of Participants  
[units: participants]
  606     388     92     1086  
Age [1]
[units: years]
Mean ± Standard Deviation
  53.0  ± 11.74     48.4  ± 11.02     51.3  ± 12.72     51.2  ± 11.76  
Gender [1]
[units: participants]
       
Female     25     17     2     44  
Male     581     371     90     1042  
Presence of Tophus [1]
[units: participants]
       
Present     116     83     15     214  
Absent     490     305     77     872  
Race/Ethnicity [1]
[units: 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  
Renal Function [2]
[units: participants]
       
Normal     593     381     92     1066  
Impaired     13     7     0     20  
Body Mass Index (BMI) [1]
[units: kg/m²]
Mean ± Standard Deviation
  31.9  ± 5.49     34.1  ± 6.71     32.4  ± 5.58     31.9  ± 5.49  
Serum Urate [1]
[units: mg/dL]
Mean ± Standard Deviation
  9.65  ± 1.20     10.05  ± 1.29     9.83  ± 1.27     9.81  ± 1.25  
[1] Based on Final Stable Treatment in study C02-021
[2] Based on Final Stable Treatment in study C02-021. Impaired defined as serum creatinine <1.5 mg/dL.



  Outcome Measures
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1.  Primary:   Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.   [ Time Frame: Month 1 ]

2.  Primary:   Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.   [ Time Frame: Month 12 ]

3.  Primary:   Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.   [ Time Frame: Month 24 ]

4.  Primary:   Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.   [ Time Frame: Month 36 ]

5.  Primary:   Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.   [ Time Frame: Last Visit on treatment (up to 40 months). ]

6.  Secondary:   Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment.   [ Time Frame: Last Visit on treatment (up to 40 months). ]

7.  Secondary:   Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline.   [ Time Frame: Month 12 ]

8.  Secondary:   Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline.   [ Time Frame: Month 24 ]

9.  Secondary:   Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline.   [ Time Frame: Month 36 ]

10.  Secondary:   Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline.   [ Time Frame: Final Visit (up to 40 months). ]

11.  Secondary:   Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit.   [ Time Frame: Final Visit (up to 40 months). ]

12.  Secondary:   Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12.   [ Time Frame: Month 12 ]

13.  Secondary:   Percentage of Subjects Requiring Treatment for Gout Flare After Month 12.   [ Time Frame: After Month 12 to Final Visit ]


  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
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.


  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: Senior Vice President, 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: NCT00175019     History of Changes
Other Study ID Numbers: C02-021, U1111-1113-9814
Study First Received: September 12, 2005
Results First Received: March 12, 2009
Last Updated: July 22, 2010
Health Authority: United States: Food and Drug Administration