Gout - Clinical trial details 

Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat

Recruitment status:
Not recruiting
Primary Sponsor:
Ardea Biosciences, Inc.
Recruitment countries:
Australia,  Canada,  New Zealand,  Poland,  Spain,  Switzerland,  United States
Health condition studied:
Tophaceous Gout
URL:
Link to the clinical trial website

About the trial

Interventions:
Drug: Lesinurad
Drug: Placebo
Key inclusion and exclusion criteria:

  • Inclusion Criteria:

    - Subject is able to understand the study procedures, the risks involved and willing to
    provide written informed consent before the first study related activity.

    - Subject is willing to adhere to the visit/protocol schedules.

    - Subject meets the diagnosis of gout as per the American Rheumatism Association

    - Criteria for the Classification of Acute Arthritis of Primary Gout.

    - Subject meets one of the following criteria:

    - Subjects who are not currently taking an approved ULT must have an sUA value of = 8
    mg/dL (476 µmol/L).

    - Subjects entering the study on a medically appropriate dose of febuxostat or
    allopurinol must have an sUA value of = 6.0 mg/dL (357 µmol/L).

    - Subject must be able to take gout flare prophylaxis with colchicine or non-steroidal
    anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.

    - Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles = 5
    mm and = 20 mm in the longest diameter.

    - Body mass index (BMI) < 45 kg/m2

    Exclusion Criteria:

    - Subject with known hypersensitivity or allergy to febuxostat.

    - Subject who is taking any approved urate-lowering medication other than allopurinol
    or febuxostat that is indicated for the treatment of gout within 8 weeks of the
    Screening Visit.

    - Subject who previously received pegloticase.

    - Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150
    mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).

    - Subject with a history or suspicion of drug abuse within the past 5 years.

    - Subject with a history of myositis/myopathy or rhabdomyolysis.

    - Subject that requires or may require systemic immunosuppressive or immunomodulatory
    treatment.

    - Subject with known or suspected human immunodeficiency virus (HIV) infection.

    - Subject with a positive test for active hepatitis B or hepatitis C infection.

    - Subject with a history of malignancy within the previous 5 years with the exception
    of non-melanoma skin cancer that has been treated with no evidence of recurrence,
    treated cervical dysplasia or treated in situ Grade 1 cervical cancer.

    - Subject within the last 12 months with: unstable angina, New York Heart Association
    thrombosis; or subjects currently receiving anticoagulants.

    - Subject with uncontrolled hypertension.

    - Subject with an estimated creatinine clearance < 30 mL/min.

    - Subjects with a creatine kinase > 2.5 x ULN at any time during the Screening Period.

    - Subject with active peptic ulcer disease requiring treatment.

    - Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.

    - Subject receiving chronic treatment with more than 325 mg of salicylates per day.

    - Subject taking valpromide, progabide, or valproic acid.

    - Subject who has received an investigational therapy within 8 weeks or 5 half-lives
    (whichever is longer) prior to the Screening Visit.

    - Subject with any other medical or psychological condition, which in the opinion of
    the Investigator and/or 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.
  • Age minimum:  18 Years
  • Age maximum:  85 Years
  • Gender:  Both
Primary outcomes:
Efficacy
Secondary outcomes:
Best Tophus Response
Complete Tophus Reduction
Quality of Life
Target sample size:
330
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
Contacts:
  • Name:   Chris Storgard, MD
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Ardea Biosciences, Inc.

Technical details

Scientific title:
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects With Tophaceous Gout
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT01510769
Secondary ID:
RDEA594-304
2011-003768-55
Register:
ClinicalTrials.gov
Date of registration:
12/01/2012
Date of first enrollment:
January 2012
Last refreshed:
21 July 2014

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