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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01808144
Registration number
NCT01808144
Ethics application status
Date submitted
7/03/2013
Date registered
11/03/2013
Date last updated
30/01/2018
Titles & IDs
Public title
Lesinurad and Febuxostat Combination Extension Study in Gout
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Scientific title
A Long-Term Extension Study of Lesinurad in Combination With Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat
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Secondary ID [1]
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2012-004390-54
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Secondary ID [2]
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RDEA594-307
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gout
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - lesinurad
Treatment: Drugs - lesinurad
Treatment: Drugs - febuxostat
Experimental: lesinurad 400 mg + febuxostat 80 mg - Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
Experimental: lesinurad 200 mg + febuxostat 80 mg -
Treatment: Drugs: lesinurad
Tablets, 400 mg once daily (QD)
Treatment: Drugs: lesinurad
Tablets, 200 mg QD
Treatment: Drugs: febuxostat
Tabletsm 80 mg QD
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With an sUA Level That is < 5.0 mg/dL
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Assessment method [1]
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Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
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Timepoint [1]
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Up to approximately 2.5 years (at Extension Month 12)
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Secondary outcome [1]
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Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
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Assessment method [1]
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Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)
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Timepoint [1]
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Up to approximatley 2.5 years (at Extension Month 12)
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Eligibility
Key inclusion criteria
- Subject is able to understand the study procedures and the risks involved and is
willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in Study RDEA594-304 and was
actively receiving and tolerating study medication (lesinurad or placebo) and
febuxostat 80 mg at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use
an effective non-hormonal method of birth control during the study and for at least 14
days after the last dose of study medication.
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject has any medical or psychological condition, which in the opinion of the
Investigator and/or the Medical Monitor, might create undue risk to the subject or
interfere with the subject's ability to comply with the protocol requirements, or to
complete the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/10/2016
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Sample size
Target
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Accrual to date
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Final
196
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS
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Recruitment hospital [1]
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- Camperdown
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Recruitment hospital [2]
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- Woodville South
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Recruitment hospital [3]
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- Hobart
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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5011 - Woodville South
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Recruitment postcode(s) [3]
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7000 - Hobart
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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California
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Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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Idaho
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Illinois
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Kentucky
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Maryland
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Michigan
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Mississippi
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Missouri
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North Carolina
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North Dakota
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Ohio
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West Virginia
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Canada
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Ontario
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New Zealand
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Auckland
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New Zealand
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Tauranga
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Poland
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Iodzkie
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Malopolskie
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Podlaskie
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Slaskie
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Switzerland
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Fribourg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Ardea Biosciences, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in
combination with febuxostat over a long-term timeframe.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01808144
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Nihar Bhakta, MD
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Address
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Ardea Biosciences, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01808144
Download to PDF