Combining Lesinurad With Allopurinol in Inadequate Responders
NCT ID: NCT01510158
Last Updated: 2016-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
607 participants
INTERVENTIONAL
2012-01-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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lesinurad 200 mg + allopurinol
Lesinurad
Tablets, 200 mg once daily (qd)
Allopurinol
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
lesinurad 400 mg + allopurinol
Lesinurad
Tablets, 400 mg qd
Allopurinol
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Placebo + allopurinol
Placebo
Tablets, Placebo qd
Allopurinol
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Interventions
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Lesinurad
Tablets, 200 mg once daily (qd)
Lesinurad
Tablets, 400 mg qd
Placebo
Tablets, Placebo qd
Allopurinol
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Allopurinol
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Allopurinol
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Eligibility Criteria
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Inclusion Criteria
* 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 Nonsteroidal anti-inflammatory drug (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
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Ardea Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Storgard, MD
Role: STUDY_DIRECTOR
Ardea Biosciences, Inc.
Locations
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Athens, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Gulf Shores, Alabama, United States
Mobile, Alabama, United States
Mobile, Alabama, United States
Pinson, Alabama, United States
Glendale, Arizona, United States
Goodyear, Arizona, United States
Little Rock, Arizona, United States
Little Rock, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tuscon, Arizona, United States
Little Rock, Arkansas, United States
Covina, California, United States
Glendale, California, United States
Huntington Beach, California, United States
Inglewood, California, United States
Lancaster, California, United States
Lincoln, California, United States
Orange, California, United States
Sacramento, California, United States
San Leandro, California, United States
Santa Maria, California, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Milford, Connecticut, United States
New London, Connecticut, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
East Bradenton, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Ocala, Florida, United States
Ormond Beach, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Conyers, Georgia, United States
Johns Creek, Georgia, United States
Marietta, Georgia, United States
Newnan, Georgia, United States
Honolulu, Hawaii, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Evansville, Indiana, United States
Franklin, Indiana, United States
La Porte, Indiana, United States
Cedar Rapids, Iowa, United States
Shawnee, Kansas, United States
Elizabethtown, Kentucky, United States
Paducah, Kentucky, United States
Eunice, Louisiana, United States
Metairie, Louisiana, United States
Monroe, Louisiana, United States
Natchitoches, Louisiana, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Southfield, Michigan, United States
Traverse City, Michigan, United States
Jackson, Mississippi, United States
Florissant, Missouri, United States
Hazelwood, Missouri, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Washington, Missouri, United States
Missoula, Montana, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Endwell, New York, United States
New York, New York, United States
Syracuse, New York, United States
Williamsville, New York, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Shelby, North Carolina, United States
Tabor City, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Perrysburg, Ohio, United States
Willoughby Hills, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Ashland, Oregon, United States
Altoona, Pennsylvania, 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
Sellersville, Pennsylvania, United States
Upper Saint Clair, Pennsylvania, United States
Wexford, Pennsylvania, United States
Columbia, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Myrtle Beach, South Carolina, United States
Rock Hill, South Carolina, United States
Spartanburg, South Carolina, United States
Brentwood, Tennessee, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Kingwood, Texas, United States
Nassau Bay, Texas, United States
Plabo, Texas, United States
Plano, Texas, United States
San Angelo, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Sealy, Texas, United States
Waco, Texas, United States
Bountiful, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Chesapeake, Virginia, United States
Manassas, Virginia, United States
Midlothian, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Virginia Beach, Virginia, United States
Port Orchard, Washington, United States
Spokane, Washington, United States
Spokane, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Countries
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References
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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.
Saag KG, Fitz-Patrick D, Kopicko J, Fung M, Bhakta N, Adler S, Storgard C, Baumgartner S, Becker MA. Lesinurad Combined With Allopurinol: A Randomized, Double-Blind, Placebo-Controlled Study in Gout Patients With an Inadequate Response to Standard-of-Care Allopurinol (a US-Based Study). Arthritis Rheumatol. 2017 Jan;69(1):203-212. doi: 10.1002/art.39840.
Related Links
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Related Info
Other Identifiers
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RDEA594-301
Identifier Type: -
Identifier Source: org_study_id
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