242
Participants
Start Date
July 19, 2017
Primary Completion Date
February 25, 2019
Study Completion Date
February 25, 2019
Lesinurad
200 mg oral tablet
XOI
All participants must be on a stable, medically appropriate dose of XOI as their sole urate-lowering therapy (ULT) indicated for the treatment of gout for at least 4 weeks prior to Screening and throughout the Screening Period. This stable dose of XOI will be maintained throughout the study period.
Placebo
matching placebo oral tablet
colchicine
Gout flare prophylaxis: commercially available colchicine is provided through the Month 6 study visit. Actual colchicine dose (0.5 or 0.6 mg qd) and frequency were adjusted based on the local label, subject medical history, and clinical judgement.
corticosteroids
Gout flare prophylaxis: Participants unable to take colchicine are permitted to take a short course of low-dose oral corticosteroids up to the Month 3 study visit
Clinexpert Kft., Budapest
Vaszary Kolos Korhaz Esztergom - Reumatologiai osztaly, Esztergom
Selye Janos Hospital - Rheumatology Department, Komárom
BKS Research Kft., Hatvan
CRU Hungary Kft., Miskolc
Allergo-Derm Bakos Kft., Szolnok
Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo, Békéscsaba
Kalocsai Szent Kereszt Korhaz, Kalocsa
Bajai Szent Rokus Korhaz, Baja
Clinfan Ltd SMO, Szekszárd
Mentahaz Maganorvosi Kozpont (SMO), Székesfehérvár
Medical Expert Kft., Veszprém
DRC Gyogyszervizsgalo Kozpont Kft, Balatonfüred
Ellipsis Research Group, LLC, Brooklyn
Winthrop University Hospital, Mineola
Buffalo VA Medical Center, Buffalo
Altoona Center for Clinical Research, Duncansville
Northeast Clinical Research Center, Bethlehem
University of Pennsylvania, Philadelphia
Manassas Clinical Research Center, Manassas
Clinical Research Partners, LLC, Richmond
Spectrum Medical, Inc., Danville
PhysiqueMed Clinical Trials, Greensboro
DJL Clinical Research PLLC, Charlotte
Trial Management Associates, LLC, Wilmington
Burke Primary Care, Morganton
Low Country Rheumatology, Charleston
Mountain View Clinical Research - Greer, Greer
Piedmont Research Partners, LLC, Fort Mill
The Kaufmann Clinic, Inc, Atlanta
Ellipsis Group, Atlanta
Arthritis, Autoimmune, & Allergy LLC, Daytona Beach
Riverside Clinical Research, Edgewater
Florida Medical Research Institute, Gainesville
Rheumatology Associates of Central Florida, Orlando
Omega Research Consultants, LLC, Orlando
Eastern Research, Hialeah
Savin Medical Group, Miami Lakes
San Marcus Research Clinic Inc, Miami
LCC Medical Research Institute, LLC, Miami
BayCare Medical Group, Inc., Tampa
Meridien Research - Tampa, Tampa
Central Alabama Research, Birmingham
Discovery Alliance International Inc. d/b/a Tennessee Health Research Alliance LLC, Nashville
Nephrology Associates, P.C., Nashville
Knoxville Kidney Center, PLLC, Knoxville
CRC of Jackson, LLC, Jackson
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ústí nad Labem
Four Rivers Clinical Research, Paducah
Center for Arthritis & Osteoporosis, Elizabethtown
Prestige Clinical Research, Franklin
Sterling Research Group, Ltd. - Auburn, Cincinnati
Sterling Research Group, Ltd. - Cincinnati, Cincinnati
Nephrology Specialists, Merrillville
St. Clair Nephrology Research, Roseville
University of Michigan, Ann Arbor
Michigan Kidney Consultants, Pontiac
CCBR Clinical Research, Pardubice, Pardubice
Clinical Investigation Specialists, Inc. - Gurnee, Gurnee
CCBR Czech Brno, s. r. o, Brno
DTTO Faculty Hospital Brno, Brno
VA Medical Center - Kansas City, Kansas City
Nemocnice Znojmo p.o - Interni oddeleni, Znojmo
Kansas Nephrology Research Institute, Wichita
Meridian Clinical Research - Norfolk, NE, Norfolk
Clinical Trials Management LLC - Southshore, Metairie
CCBR Ostrava s.r.o., Ostrava
Clinical Trials Management, LLC - Northshore, Covington
Ochsner Clinic Foundation, Baton Rouge
Northwest Louisiana Nephrology, Shreveport
Arthritis and Diabetes Clinic, Monroe
P&I Clinical Research, Lufkin
FMC Science, Lampasas
3rd Coast Research Associates, Victoria
Clinical Advancement Center, PLLC, San Antonio
Briggs Clinical Research, Inc., San Antonio
Western Nephrology-Westminster, Westminster
Rocky Mountain Diabetes and Osteoporosis Center PA, Idaho Falls
Southern Arizona VA Health Care System, Tucson
New Mexico Clinical Research & Osteoporosis Center Inc., Albuquerque
Medvin Clinical Research - Whittier, Whittier
Medvin Clinical Research, Covina
Inland Rheumatology Clinical Trials, Inc, Upland
Northern California Research, Sacramento
Capital Nephrology Medical Group, Sacramento
Columbia Research Group, Inc., Portland
New England Research Associates, Llc, Trumbull
University of Massachusetts Memorial Medical Center, Worcester
Rhode Island Hospital, East Providence
REVMACLINIC s.r.o. - Revmatologicka ambulance, Brno
Revmatologie MUDr. Bilkova s.r.o., Olomouc
CCBR Czech Prague s.r.o., Prague
MEDICAL PLUS, s.r.o. - Revmatologicka ambulance, Uherské Hradiště
PV - MEDICAL, s.r.o., Zlín
Stacja Dializ Zyrardow, Żyrardów
Centrum Dializa Sp. z o.o. - Zyrardow, Żyrardów
B_Serwis Popenda Sp. J., Chorzów
Centrum Kliniczno Badawcze J. Brzezicki B. Gornikiewicz - Brzezicka Lekarze Sp. p., Elblag
MCBK s.c., Grodzisk Mazowiecki
NZOZ Praktyka Lekarza Rodzinnego Elzbieta Kelm, Katowice
Centrum Medyczne Pratia Krakow, Krakow
Malopolskie Centrum Medyczne, Krakow
Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Oddzial Kliniczny Nefrologii, Hipertensjologii i Transplantologii Nerek, Lodz
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo Akcyjna, Lodz
AppleTreeClinics Sp. z o.o., Lodz
Centrum Medyczne AMED Oddzial w Lodzi, Lodz
NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek, Lodz
Centrum Medyczne Chodzki, Lublin
Alfa Specjalistyczne Gabinety Lekarskie Ewa Moroz, Nowy Sącz
Centrum Zdrowia Metabolicznego Pawel Bogdanski, Poznan
Centrum Badan Klinicznych s.c., Poznan
Praktyka Lekarska Ewa Krzyzagorska, Poznan
Prywatny Gabinet Lekarski NZOZ Centrum Medyczne Aeskulap, Radom
Centrum Medyczne Pratia Warszawa, Warsaw
Centrum Medyczne K2J2, Wołomin
KO - MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Zamosciu, Zamość
Lead Sponsor
Collaborators (1)
Medpace, Inc.
INDUSTRY
Ironwood Pharmaceuticals, Inc.
INDUSTRY