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Taking people in United StatesPhase 3

A Study of Dotinurad Versus Allopurinol in Participants With Gout

Key facts

Where
Ann Arbor, Atlanta, Birmingham, Bradenton, Brooklyn, Brownsburg, Charlotte, Charlottesville, Chicago, Coral Gables, Corpus Christi, Covina, Dallas, Dayton, Decatur, Denton, Denver, DeSoto, Dublin, Duncansville, Evansville, Fairfax, Flossmoor, Foley, Gilbert, Glendale, Great Falls, Greensboro, Hazelwood, Hendersonville, Hialeah, Houston, Hurst, Indianapolis, Jupiter, Katy, Lakeland, Lewisville, Louisville, Mason, Menifee, Mesa, Mesquite, Metairie, Miami, Miami Lakes, Morehead City, Naples, New Orleans, New York, Norco, North Charleston, North Las Vegas, Northridge, O'Fallon, Ogden, Oradell, Orange, Orlando, Overland Park, Oxon Hill, Pomona, Pompano Beach, Prairieville, Rapid City, Redmond, Rockville, Saint Clair Shores, San Antonio, San Bernardino, San Diego, San Leandro, San Marcos, Shelby, Southfield, Sparta, Spring Valley, Springfield, Sterling Heights, Sugar Land, Tampa, Thousand Oaks, Tomball, Town and Country, Troy, Tucson, Tujunga, Tulsa, Virginia Beach, Waltham, West Chester, West Long Branch, Wichita Falls, Willow Grove, and Winter Park, United StatesSee the 102 sites
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT07089875, who can take part

Where in United States

  • Michigan Medicine - University of MichiganAnn Arbor, United StatesContact: Puja Khanna, MDTaking people
  • DelRicht Research - AtlantaAtlanta, United StatesContact: Clinical Trial LeadNo longer taking part
  • University of Alabama at BirminghamBirmingham, United StatesContact: Kenneth Saag, MDTaking people
  • Alabama Clinical TherapeuticsBirmingham, United StatesContact: Clinical Trial LeadNo longer taking part
  • Bradenton Research CenterBradenton, United StatesContact: Eric Folkens, MDTaking people
  • Ellipsis Research GroupBrooklyn, United StatesContact: Jorge Serje, MDTaking people
  • Investigators Research GroupBrownsburg, United StatesContact: Kenneth Maynard, MDTaking people
  • DelRicht ResearchCharlotte, United StatesContact: Olabisi Badmus, MDTaking people
  • Charlottesville Medical ResearchCharlottesville, United StatesContact: James Clark, MDTaking people
  • Chicago Clinical Research Institute, Inc. (CCRII)Chicago, United StatesContact: Manognya SamaTaking people
  • Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)Chicago, United StatesContact: Manish Jain, MDTaking people
  • Herco Medical and Research Center, IncCoral Gables, United StatesContact: Eddy Capote, MDTaking people
  • Arthritis Care of TexasCorpus Christi, United StatesContact: Eric Chiang, MDTaking people
  • Medvin Clinical Research - CovinaCovina, United StatesContact: Samy Metyas, MDTaking people
  • Zenos Clinical ResearchDallas, United StatesContact: Durga Tanneru, MDTaking people
  • Hometown Urgent Care and Research - DaytonDayton, United StatesContact: Steve Choi, MDTaking people
  • Pediatrics & Adult Medicine/SKYCRNGDecatur, United StatesContact: Michele Sewell, MDTaking people
  • SKYCRNG - Rophe Adult and Pediatric MedicineDecatur, United StatesContact: Dwight Blake, MDTaking people
  • Lone Star Arthritis & Rheumatology Associates - DentonDenton, United StatesContact: Awilda (Michelle) Luciano, MDTaking people
  • Denver Arthritis Clinic - LowryDenver, United StatesContact: Christopher Antolini, MDTaking people
  • Epic Medical Research - DeSotoDeSoto, United StatesContact: Haresh Boghara, MDTaking people
  • West Coast ResearchDublin, United StatesContact: Tim DavisTaking people
  • Altoona Center For Clinical ResearchDuncansville, United StatesContact: Alan Kivitz, MDTaking people
  • MediSphere Medical Research Center, LLCEvansville, United StatesContact: Hubert Reyes, MDTaking people
  • Arthritis and Rheumatism AssociatesFairfax, United StatesContact: Daniel El-Bogdadi, MDTaking people
  • Healthcare Research Network - Tinley ParkFlossmoor, United StatesContact: Ronald Stumbris, MDTaking people
  • G&L ResearchFoley, United StatesContact: Nidal Morrar, MDTaking people
  • Arizona Arthritis & Rheumatology Associates (AARA) - GilbertGilbert, United StatesContact: Daniel Kreutz, MDTaking people
  • Arizona Arthritis & Rheumatology Associates (AARA) - GlendaleGlendale, United StatesContact: Nehad Soloman, MDTaking people
  • Boeson Research - Great FallsGreat Falls, United StatesContact: Richard Horng-Chy Lai, MDTaking people
  • Triad Clinical TrialsGreensboro, United StatesContact: Richard Montgomery, MDTaking people
  • Healthcare Research NetworkHazelwood, United StatesContact: Clinical Trial LeadNo longer taking part
  • DelRicht Research - HendersonvilleHendersonville, United StatesContact: Clinical Trial LeadNo longer taking part
  • Best Quality ResearchHialeah, United StatesContact: Gustavo Ledo-Sanchez, MDTaking people
  • New Generation of Medical ResearchHialeah, United StatesContact: Karelia Ruiz, MDTaking people
  • Pioneer Research SolutionsHouston, United StatesContact: Mozaffari ShahinTaking people
  • Prolato Clinical Research CenterHouston, United StatesContact: Michelle Eisenberg, MDTaking people
  • Epic Medical Research - HurstHurst, United StatesContact: Robert Strzinek, MDTaking people
  • Delricht Research - Better Life Direct Primary CareIndianapolis, United StatesContact: Clinical Trial LeadNo longer taking part
  • Health Awareness, IncJupiter, United StatesContact: Ronald Surowitz, MDTaking people
  • R&H Clinical Research - Westborough DriveKaty, United StatesContact: Maryam Khawari, MDTaking people
  • Clinical Research of Center FloridaLakeland, United StatesContact: Michael Gimness, MDTaking people
  • Alliance Clinical Lewisville (Epic Clinical Research)Lewisville, United StatesContact: Clinical Trial LeadNo longer taking part
  • DelRicht Research - Louisville (Derby City DPC)Louisville, United StatesContact: Michael Lovelace, MDTaking people
  • Delricht Research - Concierge Medicine Of CincinnatiMason, United StatesContact: Clinical Trial LeadNo longer taking part
  • Southland Arthritis and Osteoporosis Medical Center, IncMenifee, United StatesContact: Amal Mehta, MDTaking people
  • Arizona Arthritis & Rheumatology Associates (AARA) - MesaMesa, United StatesContact: Swati Bharadwaj, MDTaking people
  • Southwest Rheumatology ResearchMesquite, United StatesContact: Atul Singhal, MDTaking people
  • Tandem Clinical Research - Metairie ClinicMetairie, United StatesContact: Clinical Trial LeadNo longer taking part
  • Anchor Medical Research LLCMiami, United StatesContact: Juvenal Martinez, MDTaking people
  • Well Pharma Medical ResearchMiami, United StatesContact: Eddie Armas, MDTaking people
  • Panax Clinical ResearchMiami Lakes, United StatesContact: Robert G. Perry, MDTaking people
  • Carteret Medical Group LLCMorehead City, United StatesContact: Mary Lawrence, MDTaking people
  • UltraHealth, LLCNaples, United StatesContact: Carolina Otero, MDTaking people
  • DelRicht Research - LCMC Health Urgent Care - LakeviewNew Orleans, United StatesContact: Emily KrambeckTaking people
  • NYU Langone HealthNew York, United StatesContact: Michael Pillinger, MDTaking people
  • Infinity Clinical ResearchNorco, United StatesContact: Peter Mattar, MDTaking people
  • Coastal Carolina Research Center - MainNorth Charleston, United StatesContact: Rica Santiago, MDTaking people
  • Las Vegas Clinical TrialsNorth Las Vegas, United StatesContact: Alton Walters, MDTaking people
  • Amicis Research Center - BalboaNorthridge, United StatesContact: Pascal Dabel, MDTaking people
  • Gateway Clinical TrialsO'Fallon, United StatesContact: Christopher Anderson, MDTaking people
  • Ogden Clinic Canyon View/RIO Clinical TrialsOgden, United StatesContact: Stephen Bruce, MDTaking people
  • Curalta Clinical TrialsOradell, United StatesContact: Vincent Giacalone, MDTaking people
  • Cure Clinical ResearchOrange, United StatesContact: Ramprasad Dandillaya, MDTaking people
  • Omega Research DeBaryOrlando, United StatesContact: Kwabena Ayesu, MDTaking people
  • Delricht Research - Concierge And Direct Primary CareOverland Park, United StatesContact: Jonathan T. Jacobs, MDTaking people
  • MD Medical Research - Oxon HillOxon Hill, United StatesContact: Stephen Ong, MDTaking people
  • Dream Team Clinical ResearchPomona, United StatesContact: Clinical Trial LeadNo longer taking part
  • D & H Pompano Research CenterPompano Beach, United StatesContact: Mazyar Rouhani, MDTaking people
  • DelRicht Research - PrairievillePrairieville, United StatesContact: Clinical Trial LeadNo longer taking part
  • Health ConceptsRapid City, United StatesContact: Richard Beasley, MDTaking people
  • Eastside Research AssociatesRedmond, United StatesContact: Christopher Price, MDTaking people
  • DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)Rockville, United StatesContact: Clinical Trial LeadNo longer taking part
  • Clinical Research Institute of Michigan - St. Clair ShoresSaint Clair Shores, United StatesContact: Amar Majjhoo, MDTaking people
  • Discovery Clinical TrialsSan Antonio, United StatesContact: Abha Gyani, MDTaking people
  • ERG - Endeavor Clinical TrialsSan Antonio, United StatesContact: Nitendra Agarwal, MDTaking people
  • Velocity Clinical Research, San BernardinoSan Bernardino, United StatesContact: Judith Albay, MDTaking people
  • Acclaim Clinical Research, Inc.San Diego, United StatesContact: Julie Vu, MDTaking people
  • East Bay Rheumatology Medical GroupSan Leandro, United StatesContact: Suneet Grewal, MDTaking people
  • Epic Medical Research - San MarcosSan Marcos, United StatesContact: Maria De Jesus Salinas, MDTaking people
  • Shelby Clinical Research, LLC - North CarolinaShelby, United StatesContact: Christian Martin, MDTaking people
  • DM Clinical Research - DetroitSouthfield, United StatesContact: Clinical Trial LeadNo longer taking part
  • Premier Health ResearchSparta, United StatesContact: Haroon Sarwar, MDTaking people
  • BTC Network - Encompass Clinical ResearchSpring Valley, United StatesContact: Hanid Audish, MDTaking people
  • Delricht Research - Command Family MedicineSpringfield, United StatesContact: Clinical Trial LeadNo longer taking part
  • Revive Research Institute - Sterling HeightsSterling Heights, United StatesContact: Syed Ali Muttaqi Husain, MDTaking people
  • Siena Research NetworkSugar Land, United StatesContact: Mehjabin Parkar, MDTaking people
  • Clinical Research Trials of FloridaTampa, United StatesContact: Viviana FonsecaTaking people
  • Cohen Medical CentersThousand Oaks, United StatesContact: Shariar Cohen-Gadol, MDTaking people
  • DM Clinical Research - Tomball - Multiple SpecialtiesTomball, United StatesContact: Shaikh Ali, MDTaking people
  • DelRicht Research - Town and CountryTown and Country, United StatesContact: Amy E. Roberts, MDTaking people
  • Oakland Medical CenterTroy, United StatesContact: Jay Sandberg, MDTaking people
  • Del Sol Research Management - Tucson EastTucson, United StatesContact: Vicki Kalen, MDTaking people
  • Medvin Clinical Research - TujungaTujunga, United StatesContact: Clinical Trial LeadNo longer taking part
  • DelRicht Research - TulsaTulsa, United StatesContact: Clinical Trial LeadNo longer taking part
  • Gershon Pain SpecialistsVirginia Beach, United StatesContact: Steven Gershon, MDTaking people
  • MedVadis ResearchWaltham, United StatesContact: David DiBenedetto, MDTaking people
  • Suburban Research Associates - West Chester OfficeWest Chester, United StatesContact: Clinical Trial LeadNo longer taking part
  • Sahni Rheumatology & TherapyWest Long Branch, United StatesContact: Kiren Sahni, MDTaking people
  • Digestive Health Research of North TexasWichita Falls, United StatesContact: Vanya Wagler, MDTaking people
  • Rheumatic Disease AssociatesWillow Grove, United StatesContact: Elana Eisner, MDTaking people
  • Conquest Research-Winter ParkWinter Park, United StatesContact: Anand Patel, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Crystalys Therapeutics
Trial code
NCT07089875EU 2024-520206-19-00
Record updated
12 November 2026
Original description
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.Read full original descriptionShow less

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout

The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.

Inclusion: Between 18 and 75 years of age (inclusive) at the time of signing informed consent; Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year; Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records); Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment as documented in the participant's medical history) up to 600 mg/day for at least 3 months prior to Screening and remain on their dosing regimen until Day 1; sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit); Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding; Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of study drug.

Exclusion: History of or presence of kidney stones within 1 year prior to Screening; History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma; Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs; Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse; Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening; Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.

ClinicalTrials.gov NCT07089875 · EU CTIS 2024-520206-19-00