Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01493531




Registration number
NCT01493531
Ethics application status
Date submitted
13/12/2011
Date registered
16/12/2011
Date last updated
26/05/2016

Titles & IDs
Public title
Combining Lesinurad With Allopurinol in Inadequate Responders
Scientific title
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects With Gout Who Have Had an Inadequate Hypouricemic Response to Standard of Care Allopurinol
Secondary ID [1] 0 0
2011-003767-29
Secondary ID [2] 0 0
RDEA594-302
Universal Trial Number (UTN)
Trial acronym
CLEAR 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lesinurad
Treatment: Drugs - Lesinurad
Treatment: Drugs - Placebo
Treatment: Drugs - Allopurinol

Experimental: lesinurad 200 mg + allopurinol -

Experimental: lesinurad 400 mg + allopurinol -

Placebo comparator: Placebo + allopurinol -


Treatment: Drugs: Lesinurad
Tablets, 200 mg QD

Treatment: Drugs: Lesinurad
Tablets, 400 mg QD

Treatment: Drugs: Placebo
Tablets, Placebo QD

Treatment: Drugs: Allopurinol
Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Gout Flares
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
Subjects With = 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12
Timepoint [2] 0 0
12 months

Eligibility
Key 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 meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
* Subject has been taking allopurinol as the sole urate-lowering therapy indicated for the treatment of gout for at least 8 weeks prior to the Screening Visit at a stable, medically appropriate dose, as determined by the investigator, of at least 300 mg per day (at least 200 mg for subjects with moderate renal impairment).
* Subject must be able to take gout flare prophylaxis with colchicine or an NSAID (including Cox-2 selective NSAID) ±PPI.
* Subject has an sUA level = 6.5 mg/dL at the Screening Visit and = 6.0 mg/dL at Day -7 Visit.
* Subject has reported at least 2 gout flares in the prior 12 months.
* Body mass index (BMI) < 45 kg/m2
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject with known hypersensitivity or allergy to allopurinol.
* Subject who is taking any other approved urate-lowering medication that is indicated for the treatment of gout other than allopurinol within 8 weeks of the Screening Visit.
* Subject who is pregnant or breastfeeding.
* 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 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 class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
* Subject with uncontrolled hypertension.
* Subject with an estimated creatinine clearance < 30 mL/min.
* 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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
610
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown,
Recruitment hospital [2] 0 0
- Wollongong
Recruitment hospital [3] 0 0
- Bisbane
Recruitment hospital [4] 0 0
- Herston
Recruitment hospital [5] 0 0
- Woodville South
Recruitment hospital [6] 0 0
- Clayton
Recruitment hospital [7] 0 0
- Heidelberg West
Recruitment hospital [8] 0 0
- Perth
Recruitment hospital [9] 0 0
- Shenton Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown,
Recruitment postcode(s) [2] 0 0
2522 - Wollongong
Recruitment postcode(s) [3] 0 0
4152 - Bisbane
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [8] 0 0
6001 - Perth
Recruitment postcode(s) [9] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
Belgium
State/province [35] 0 0
Limburg
Country [36] 0 0
Belgium
State/province [36] 0 0
Gozee
Country [37] 0 0
Belgium
State/province [37] 0 0
Kortrijk
Country [38] 0 0
Belgium
State/province [38] 0 0
Lommel
Country [39] 0 0
Belgium
State/province [39] 0 0
Mouscron
Country [40] 0 0
Belgium
State/province [40] 0 0
Yvoir
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Newfoundland and Labrador
Country [43] 0 0
Canada
State/province [43] 0 0
Nova Scotia
Country [44] 0 0
Canada
State/province [44] 0 0
Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
Germany
State/province [46] 0 0
Sachsen
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Dresden
Country [49] 0 0
Germany
State/province [49] 0 0
Eichstatt
Country [50] 0 0
Germany
State/province [50] 0 0
Goch
Country [51] 0 0
Germany
State/province [51] 0 0
Leipzig
Country [52] 0 0
Germany
State/province [52] 0 0
Mannheim
Country [53] 0 0
Germany
State/province [53] 0 0
Munich
Country [54] 0 0
Germany
State/province [54] 0 0
Osnabruck
Country [55] 0 0
New Zealand
State/province [55] 0 0
Bay of Plenty
Country [56] 0 0
New Zealand
State/province [56] 0 0
Christchurch
Country [57] 0 0
New Zealand
State/province [57] 0 0
Hamilton
Country [58] 0 0
New Zealand
State/province [58] 0 0
Rotorua
Country [59] 0 0
New Zealand
State/province [59] 0 0
Auckland
Country [60] 0 0
New Zealand
State/province [60] 0 0
Takapuna
Country [61] 0 0
Poland
State/province [61] 0 0
Malopolskie
Country [62] 0 0
Poland
State/province [62] 0 0
Podlaskie
Country [63] 0 0
Poland
State/province [63] 0 0
Warminsko-Mazurskie
Country [64] 0 0
Poland
State/province [64] 0 0
Katowice
Country [65] 0 0
Poland
State/province [65] 0 0
Konskie
Country [66] 0 0
Poland
State/province [66] 0 0
Krakow
Country [67] 0 0
Poland
State/province [67] 0 0
Poznan
Country [68] 0 0
Poland
State/province [68] 0 0
Radom
Country [69] 0 0
Poland
State/province [69] 0 0
Warszawa
Country [70] 0 0
Poland
State/province [70] 0 0
Wroclaw
Country [71] 0 0
South Africa
State/province [71] 0 0
Bloemfontein
Country [72] 0 0
South Africa
State/province [72] 0 0
Cape Town
Country [73] 0 0
South Africa
State/province [73] 0 0
Durban
Country [74] 0 0
South Africa
State/province [74] 0 0
Johannesburg
Country [75] 0 0
South Africa
State/province [75] 0 0
Western Cape
Country [76] 0 0
South Africa
State/province [76] 0 0
East London
Country [77] 0 0
South Africa
State/province [77] 0 0
Paarl
Country [78] 0 0
South Africa
State/province [78] 0 0
Pretoria
Country [79] 0 0
South Africa
State/province [79] 0 0
Soweto
Country [80] 0 0
South Africa
State/province [80] 0 0
Thabazimbi
Country [81] 0 0
South Africa
State/province [81] 0 0
Witbank
Country [82] 0 0
South Africa
State/province [82] 0 0
Worcester
Country [83] 0 0
Spain
State/province [83] 0 0
Galicia
Country [84] 0 0
Spain
State/province [84] 0 0
Vizcaya
Country [85] 0 0
Spain
State/province [85] 0 0
Merida
Country [86] 0 0
Switzerland
State/province [86] 0 0
Lausanne
Country [87] 0 0
Ukraine
State/province [87] 0 0
Dnipropetrovsk
Country [88] 0 0
Ukraine
State/province [88] 0 0
Kharkiv
Country [89] 0 0
Ukraine
State/province [89] 0 0
Kyiv
Country [90] 0 0
Ukraine
State/province [90] 0 0
Lutsk
Country [91] 0 0
Ukraine
State/province [91] 0 0
Poltava
Country [92] 0 0
Ukraine
State/province [92] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ardea Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Storgard, MD
Address 0 0
Ardea Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01493531