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Trial record 1 of 1 for:    TMX-67_204
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Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01078389
First Posted: March 2, 2010
Last Update Posted: September 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
Results First Submitted: September 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Joint Damage
Interventions: Drug: Febuxostat
Drug: Placebo for 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
Participants took part in the study at 65 investigative sites in the United States from 10 March 2010 to 3 September 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of gout were enrolled equally in 1 of 2 treatment groups, once a day placebo or febuxostat 40 mg or 80 mg based on serum urate levels.

Reporting Groups
  Description
Febuxostat 40 mg or 80 mg Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
Placebo Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.

Participant Flow:   Overall Study
    Febuxostat 40 mg or 80 mg   Placebo
STARTED   157   157 
COMPLETED   93   90 
NOT COMPLETED   64   67 
Adverse Event                10                6 
Major Protocol Deviation                2                0 
Lost to Follow-up                23                23 
Voluntary Withdrawal                20                36 
Other                9                2 



  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 or 80 mg Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
Placebo Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Total Total of all reporting groups

Baseline Measures
   Febuxostat 40 mg or 80 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 157   157   314 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.4  (12.36)   50.1  (11.72)   50.8  (12.04) 
Age, Customized 
[Units: Participants]
     
<45 years   49   42   91 
45 to <65 years   85   99   184 
≥65 years   23   16   39 
Gender 
[Units: Participants]
     
Female   14   12   26 
Male   143   145   288 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   8   10   18 
Black or African American   25   24   49 
Native Hawaiian or Other Pacific Islander   1   0   1 
White   119   121   240 
Other   3   2   5 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   26   36   62 
Not Hispanic or Latino   131   121   252 
Region of Enrollment 
[Units: Participants]
     
United States   157   157   314 
Height 
[Units: Cm]
Mean (Standard Deviation)
 176.3  (9.22)   176.5  (8.36)   176.4  (8.79) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 102.8  (20.88)   100.7  (21.20)   101.7  (21.04) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 33.1  (6.40)   32.3  (6.23)   32.7  (6.32) 
BMI Categories 
[Units: Participants]
     
<25 kg/m^2   11   11   22 
25 to <30 kg/m^2   37   46   83 
≥30 kg/m^2   109   100   209 
Smoking History 
[Units: Participants]
     
Never Smoked   84   94   178 
Current Smoker   32   25   57 
Ex-Smoker   41   38   79 
Alcohol History 
[Units: Participants]
     
Never Drank   37   35   72 
Current Drinker   103   106   209 
Ex-Drinker   17   16   33 
Renal History (Modification of Diet in Renal Disease [MDRD]) 
[Units: Participants]
     
Moderately Impaired MDRD   3   2   5 
Mildly Impaired MDRD   105   115   220 
Normal MDRD   49   40   89 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint   [ Time Frame: Baseline and Month 24 ]

2.  Secondary:   Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs   [ Time Frame: Baseline and Month 24 ]

3.  Secondary:   Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs   [ Time Frame: Baseline and Month 24 ]

4.  Secondary:   Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint   [ Time Frame: Baseline and Month 24 ]

5.  Secondary:   Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint   [ Time Frame: Baseline and Month 24 ]


  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: Medical Director, Clinical Science
Organization: Takeda
phone: +1-877-825-3327
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01078389     History of Changes
Other Study ID Numbers: TMX-67_204
U1111-1113-8098 ( Registry Identifier: WHO )
First Submitted: February 26, 2010
First Posted: March 2, 2010
Results First Submitted: September 3, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014