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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.
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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 
Overall Participants Analyzed 
[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) 
[1] Based on Final Stable Treatment in study C02-021
Gender [1] 
[Units: Participants]
       
Female   25   17   2   44 
Male   581   371   90   1042 
[1] Based on Final Stable Treatment in study C02-021
Presence of Tophus [1] 
[Units: Participants]
       
Present   116   83   15   214 
Absent   490   305   77   872 
[1] Based on Final Stable Treatment in study C02-021
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 
[1] Based on Final Stable Treatment in study C02-021
Renal Function [1] 
[Units: Participants]
       
Normal   593   381   92   1066 
Impaired   13   7   0   20 
[1] Based on Final Stable Treatment in study C02-021. Impaired defined as serum creatinine <1.5 mg/dL.
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) 
[1] Based on Final Stable Treatment in study C02-021
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


  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 ( Registry Identifier: WHO )
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