Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
NCT ID: NCT01510769
Last Updated: 2016-05-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2012-01-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lesinurad and Febuxostat Combination Extension Study in Gout
NCT01808144
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
NCT01508702
Combining Lesinurad With Allopurinol in Inadequate Responders
NCT01493531
Combining Lesinurad With Allopurinol in Inadequate Responders
NCT01510158
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
NCT01082640
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
lesinurad 400 mg + febuxostat 80 mg
Lesinurad
Tablets, 400 mg once daily (QD)
Febuxostat
80 mg
lesinurad 200 mg + febuxostat 80 mg
Lesinurad
Tablets, 200 mg QD
Febuxostat
80 mg
placebo + febuxostat 80 mg
Placebo
Tablets, Placebo QD
Febuxostat
80 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lesinurad
Tablets, 400 mg once daily (QD)
Lesinurad
Tablets, 200 mg QD
Placebo
Tablets, Placebo QD
Febuxostat
80 mg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ardea Biosciences, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chris Storgard, MD
Role: STUDY_DIRECTOR
Ardea Biosciences, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Goodyear, Arizona, United States
Peoria, Arizona, United States
Pheonix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Glendale, California, United States
Huntington Beach, California, United States
Irvine, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Rancho Cucamonga, California, United States
San Diego, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Trumball, Connecticut, United States
Washington D.C., District of Columbia, United States
Boynton Beach, Florida, United States
Brooksville, Florida, United States
East Brandenton, Florida, United States
Fleming Island, Florida, United States
Miami, Florida, United States
Napels, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Winter Haven, Florida, United States
Conyers, Georgia, United States
Johns Creek, Georgia, United States
Newnan, Georgia, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Meridian, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Springfield, Illinois, United States
Springfield, Illinois, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
Frederick, Maryland, United States
Kalamazoo, Michigan, United States
Southfield, Michigan, United States
Jackson, Mississippi, United States
Olive Branch, Mississippi, United States
Jefferson City, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Mineola, New York, United States
New York, New York, United States
Calabash, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Middleburg, Ohio, United States
Wadsworth, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Belle Vernon, Pennsylvania, United States
Clairton, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Scottdale, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Spartanburg, South Carolina, United States
Jackson, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Victoria, Texas, United States
Waco, Texas, United States
Chesapeake, Virginia, United States
Danville, Virginia, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Camperdown, New South Wales, Australia
Woodville South, South Australia, Australia
Hobart, Tasmania, Australia
Shenton Park, Western Australia, Australia
Kelowna, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Grafton, Auckland, New Zealand
Tauranga, Bay of Plenty, New Zealand
Hamilton, , New Zealand
Kutno, Lodz Province, Poland
Biatystok, , Poland
Elblag, , Poland
Gmina Końskie, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Poznan, , Poland
Poznan, , Poland
Lausanne, Vlaud, Switzerland
Fribourg, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.
Dalbeth N, Jones G, Terkeltaub R, Khanna D, Fung M, Baumgartner S, Perez-Ruiz F. Efficacy and safety during extended treatment of lesinurad in combination with febuxostat in patients with tophaceous gout: CRYSTAL extension study. Arthritis Res Ther. 2019 Jan 7;21(1):8. doi: 10.1186/s13075-018-1788-4.
Dalbeth N, Jones G, Terkeltaub R, Khanna D, Kopicko J, Bhakta N, Adler S, Fung M, Storgard C, Baumgartner S, Perez-Ruiz F. Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial. Arthritis Rheumatol. 2017 Sep;69(9):1903-1913. doi: 10.1002/art.40159. Epub 2017 Aug 4.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-003768-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RDEA594-304
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.