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RECRUITING
NCT07089888
PHASE3

A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

Sponsor: Crystalys Therapeutics

View on ClinicalTrials.gov

Summary

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 tophaceous gout.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-08-04

Completion Date

2027-12-31

Last Updated

2026-03-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Allopurinol

Over-encapsulated tablets containing active drug substance administered orally (PO).

DRUG

Dotinurad

Over-encapsulated tablets containing active drug substance administered PO.

Locations (77)

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

G & L Research

Foley, Alabama, United States

Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert

Gilbert, Arizona, United States

Arizona Arthritis & Rheumatology Associates (AARA) - Glendale

Glendale, Arizona, United States

Arizona Arthritis & Rheumatology Associates (AARA) - Mesa

Mesa, Arizona, United States

Del Sol Research Management - Tucson East

Tucson, Arizona, United States

Medvin Clinical Research - Covina

Covina, California, United States

West Coast Research

Dublin, California, United States

Infinity Clinical Research

Norco, California, United States

Amicis Research Center - Balboa

Northridge, California, United States

Dream Team Clinical Research

Pomona, California, United States

Acclaim Clinical Research, Inc.

San Diego, California, United States

East Bay Rheumatology Medical Group

San Leandro, California, United States

BTC Network - Encompass Clinical Research

Spring Valley, California, United States

Cohen Medical Centers

Thousand Oaks, California, United States

Medvin Clinical Research - Tujunga

Tujunga, California, United States

Denver Arthritis Clinic - Lowry

Denver, Colorado, United States

Bradenton Research Center

Bradenton, Florida, United States

Herco Medical and Research Center, Inc

Coral Gables, Florida, United States

New Generation of Medical Research

Hialeah, Florida, United States

Best Quality Research

Hialeah, Florida, United States

Health Awareness Inc

Jupiter, Florida, United States

Clinical Research of Center Florida

Lakeland, Florida, United States

D&H Pompano Research Center

Margate, Florida, United States

Anchor Medical Research, LLC

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Omega Research DeBary

Orlando, Florida, United States

Clinical Research Trials of Florida

Tampa, Florida, United States

Conquest Research - Winter Park

Winter Park, Florida, United States

DelRicht Research - Atlanta

Atlanta, Georgia, United States

Chicago Clinical Research Institute, Inc. (CCRII)

Chicago, Illinois, United States

Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

Chicago, Illinois, United States

MediSphere Medical Research Center, LLC - East

Evansville, Indiana, United States

Delricht Research - Better Life Direct Primary Care

Indianapolis, Indiana, United States

Delricht Research - Concierge And Direct Primary Care

Overland Park, Kansas, United States

DelRicht Research - Louisville (Derby City DPC)

Louisville, Kentucky, United States

Tandem Clinical Research - Metairie Clinic

Metairie, Louisiana, United States

DelRicht Research - LCMC Health Urgent Care - Lakeview

New Orleans, Louisiana, United States

DelRicht Research - Prairieville

Prairieville, Louisiana, United States

MD Medical Research - Oxon Hill

Oxon Hill, Maryland, United States

DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)

Rockville, Maryland, United States

MedVadis Research

Waltham, Massachusetts, United States

A. Alfred Taubman Health Care Center

Ann Arbor, Michigan, United States

DM Clinical Research - Detroit

Southfield, Michigan, United States

Revival Research Institute - Sterling Heights

Sterling Heights, Michigan, United States

Oakland Medical Center

Troy, Michigan, United States

Delricht Research - Command Family Medicine

Springfield, Missouri, United States

DelRicht Research - Town and Country

Town and Country, Missouri, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Ellipsis Research Group

Brooklyn, New York, United States

New York University Langone Orthopedic Center

New York, New York, United States

DelRicht Research - Charlotte (Direct Primary Care - DPC)

Charlotte, North Carolina, United States

Shelby Clinical Research, LLC - North Carolina

Shelby, North Carolina, United States

Hometown Urgent Care and Research - Dayton

Dayton, Ohio, United States

Delricht Research - Concierge Medicine Of Cincinnati

Mason, Ohio, United States

DelRicht Research - Tulsa

Tulsa, Oklahoma, United States

Suburban Research Associates - West Chester Office

West Chester, Pennsylvania, United States

Coastal Carolina Research Center - Main

North Charleston, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

DelRicht Research - Hendersonville

Hendersonville, Tennessee, United States

Arthritis & Osteoporosis Center of Coastal Bend

Corpus Christi, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

Lone Star Arthritis & Rheumatology Associates - Denton

Denton, Texas, United States

Epic Medical Research - DeSoto

DeSoto, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

Pioneeer Research Solutions

Houston, Texas, United States

R & H Clinical Research - South Fry Road

Katy, Texas, United States

Premise Clinical Research Center

Lancaster, Texas, United States

Alliance Clinical Lewisville (Epic Clinical Research)

Lewisville, Texas, United States

Southwest Rheumatology Research

Mesquite, Texas, United States

Discovery Clinical Trials

San Antonio, Texas, United States

ERG - Endeavor Clinical Trials

San Antonio, Texas, United States

Siena Research Network

Sugar Land, Texas, United States

DM Clinical Research - Tomball - Multiple Specialties

Tomball, Texas, United States

Rio Clinical Trials - Corporate Office

Ogden, Utah, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Gershon Pain Specialists

Virginia Beach, Virginia, United States