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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01510769
First received: January 12, 2012
Last updated: April 20, 2016
Last verified: April 2016
Results First Received: January 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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  
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  
[1] <65 Years, >=65 Years



  Outcome Measures
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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 )
Study First Received: January 12, 2012
Results First Received: January 14, 2016
Last Updated: April 20, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic