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Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat (CRYSTAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510769
First Posted: January 16, 2012
Last Update Posted: May 26, 2016
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):
Ardea Biosciences, Inc.
Results First Submitted: January 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Tophaceous Gout
Interventions: Drug: Lesinurad
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
330 participants were randomized and 324 participants were included in the Intent-to-Treat (ITT) population (ie, 6 subjects were randomized but not treated).

Reporting Groups
  Description
Lesinurad 200 mg + Febuxostat No text entered.
Lesinurad 400 mg + Febuxostat No text entered.
Placebo + Febuxostat No text entered.

Participant Flow:   Overall Study
    Lesinurad 200 mg + Febuxostat   Lesinurad 400 mg + Febuxostat   Placebo + Febuxostat
STARTED   106   109   109 
COMPLETED   79   84   87 
NOT COMPLETED   27   25   22 
Adverse Event                7                6                4 
Gout Flare                0                3                1 
Protocol Violation                11                10                9 
Lost to Follow-up                5                1                5 
Withdrawal by Subject                3                4                3 
Death                1                1                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
Lesinurad 200 mg + Febuxostat No text entered.
Lesinurad 400 mg + Febuxostat No text entered.
Placebo + Febuxostat No text entered.
Total Total of all reporting groups

Baseline Measures
   Lesinurad 200 mg + Febuxostat   Lesinurad 400 mg + Febuxostat   Placebo + Febuxostat   Total 
Overall Participants Analyzed 
[Units: Participants]
 106   109   109   324 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.2  (11.0)   53.3  (11.2)   54.6  (10.9)   54.1  (11.0) 
Age, Customized [1] 
[Units: Participants]
       
<65 Years   89   90   89   268 
>=65 Years   17   19   20   56 
[1] <65 Years, >=65 Years
Gender 
[Units: Participants]
       
Female   6   7   2   15 
Male   100   102   107   309 
Region of Enrollment 
[Units: Participants]
       
Australia   6   6   4   16 
Canada   9   2   6   17 
New Zealand   2   6   5   13 
Poland   8   10   14   32 
Switzerland   0   1   1   2 
United States   81   84   79   244 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6   [ Time Frame: 6 months, analysis after all subjects complete 12 months ]

2.  Secondary:   Complete Resolution of at Least One Target Tophus   [ Time Frame: 12 Months ]

3.  Secondary:   Complete or Partial Response of at Least One Tophus   [ Time Frame: 12 Months ]

4.  Secondary:   Quality of Life   [ Time Frame: 12 Months ]


  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: Maple Fung, MD
Organization: Ardea Biosciences, Inc.
phone: 1-858-652-6671
e-mail: mfung@ardeabio.com



Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01510769     History of Changes
Other Study ID Numbers: RDEA594-304
2011-003768-55 ( EudraCT Number )
First Submitted: January 12, 2012
First Posted: January 16, 2012
Results First Submitted: January 14, 2016
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016