Actively Recruiting
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Led by Crystalys Therapeutics · Updated on 2026-05-13
500
Participants Needed
100
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- Diagnosed with gout according to 2015 ACR-EULAR criteria for at least 1 year.
- Experienced at least 2 gout flares in the 12 months before screening.
- On a stable background allopurinol dose of 65300 mg/day (200 mg/day for moderate renal impairment) up to 600 mg/day for at least 3 months before screening and continuing until Day 1.
- Serum uric acid level 65.5 mg/dL at both screening visits.
- Female participants of childbearing potential must have negative pregnancy tests at screening and on Day 1 and must not be breastfeeding.
- Fertile males and females of childbearing potential must agree to abstain from heterosexual sex or use acceptable contraception from consent signing through 30 days after last study drug dose.
You will not qualify if you...
- History or presence of kidney stones within 1 year before screening.
- History or presence of malignancy in the last 5 years except treated basal or squamous cell skin cancer.
- Hypersensitivity or intolerance to dotinurad, colchicine, or nonsteroidal anti-inflammatory drugs.
- Known or suspected drug abuse, positive drug test at screening, or recent alcohol abuse.
- Known history or positive tests for HIV, Hepatitis B surface antigen, or Hepatitis C antibodies during screening.
- Presence of any clinically significant disease or condition that may affect safety, compliance, or study result interpretation as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 100 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Withdrawn
3
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, Arizona, United States, 85297
Actively Recruiting
4
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, Arizona, United States, 85306
Actively Recruiting
5
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, Arizona, United States, 85110
Actively Recruiting
6
Del Sol Research Management - Tucson East
Tucson, Arizona, United States, 85715
Actively Recruiting
7
Del Sol Research Management - Tucson
Tucson, Arizona, United States, 85715
Actively Recruiting
8
Medvin Clinical Research - Covina
Covina, California, United States, 91722
Actively Recruiting
9
West Coast Research
Dublin, California, United States, 94568
Actively Recruiting
10
Infinity Clinical Research
Norco, California, United States, 92860
Actively Recruiting
11
Amicis Research Center - Balboa
Northridge, California, United States, 91324
Actively Recruiting
12
Dream Team Clinical Research
Pomona, California, United States, 91767
Withdrawn
13
Velocity Clinical Research - San Bernardino
San Bernardino, California, United States, 92408
Actively Recruiting
14
Acclaim Clinical Research, Inc.
San Diego, California, United States, 92120
Actively Recruiting
15
East Bay Rheumatology Medical Group
San Leandro, California, United States, 94578
Actively Recruiting
16
BTC Network - Encompass Clinical Research
Spring Valley, California, United States, 91978
Actively Recruiting
17
Cohen Medical Centers
Thousand Oaks, California, United States, 91360-3967
Actively Recruiting
18
Medvin Clinical Research - Tujunga
Tujunga, California, United States, 91042
Actively Recruiting
19
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States, 80230
Actively Recruiting
20
Bradenton Research Center
Bradenton, Florida, United States, 34205
Actively Recruiting
21
Herco Medical and Research Center, Inc
Coral Gables, Florida, United States, 33134
Actively Recruiting
22
New Generation of Medical Research
Hialeah, Florida, United States, 32016
Actively Recruiting
23
Best Quality Research
Hialeah, Florida, United States, 33016
Actively Recruiting
24
Health Awareness Inc
Jupiter, Florida, United States, 33458
Actively Recruiting
25
Clinical Research of Center Florida
Lakeland, Florida, United States, 33805
Actively Recruiting
26
Anchor Medical Research, LLC
Miami, Florida, United States, 33176
Actively Recruiting
27
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Actively Recruiting
28
Omega Research DeBary
Orlando, Florida, United States, 32808
Actively Recruiting
29
D&H Pompano Research Center
Pompano Beach, Florida, United States, 33064
Actively Recruiting
30
Clinical Research Trials of Florida
Tampa, Florida, United States, 33607
Actively Recruiting
31
Conquest Research - Winter Park
Winter Park, Florida, United States, 32789
Actively Recruiting
32
DelRicht Research - Atlanta
Atlanta, Georgia, United States, 30329
Withdrawn
33
Chicago Clinical Research Institute, Inc. (CCRII)
Chicago, Illinois, United States, 60607
Actively Recruiting
34
Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
Chicago, Illinois, United States, 60640
Actively Recruiting
35
Healthcare Research Network - Tinley Park
Flossmoor, Illinois, United States, 60402
Actively Recruiting
36
Investigators Research Group
Brownsburg, Indiana, United States, 46112
Actively Recruiting
37
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
Actively Recruiting
38
Delricht Research - Better Life Direct Primary Care
Indianapolis, Indiana, United States, 46202
Withdrawn
39
Delricht Research - Concierge And Direct Primary Care
Overland Park, Kansas, United States, 66223
Actively Recruiting
40
DelRicht Research - Louisville (Derby City DPC)
Louisville, Kentucky, United States, 40205
Actively Recruiting
41
Tandem Clinical Research - Metairie Clinic
Metairie, Louisiana, United States, 70006
Actively Recruiting
42
DelRicht Research - LCMC Health Urgent Care - Lakeview
New Orleans, Louisiana, United States, 70124
Actively Recruiting
43
DelRicht Research - Prairieville
Prairieville, Louisiana, United States, 70769
Actively Recruiting
44
MD Medical Research - Oxon Hill
Oxon Hill, Maryland, United States, 20745
Actively Recruiting
45
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
Rockville, Maryland, United States, 20852
Withdrawn
46
MedVadis Research
Waltham, Massachusetts, United States, 02451
Actively Recruiting
47
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, United States, 48109-5000
Actively Recruiting
48
Clinical Research Institute of Michigan - St. Clair Shores
Saint Clair Shores, Michigan, United States, 48081
Actively Recruiting
49
DM Clinical Research - Detroit
Southfield, Michigan, United States, 48076
Withdrawn
50
Revive Research Institute - Sterling Heights
Sterling Heights, Michigan, United States, 48313
Actively Recruiting
51
Oakland Medical Center
Troy, Michigan, United States, 48085
Actively Recruiting
52
Healthcare Research Network
Hazelwood, Missouri, United States, 63042
Withdrawn
53
Delricht Research - Command Family Medicine
Springfield, Missouri, United States, 65807
Withdrawn
54
DelRicht Research - Town and Country
Town and Country, Missouri, United States, 63017
Actively Recruiting
55
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States, 89030
Actively Recruiting
56
Ellipsis Research Group
Brooklyn, New York, United States, 11215
Actively Recruiting
57
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
58
DelRicht Research
Charlotte, North Carolina, United States, 28210
Actively Recruiting
59
Carteret Medical Group LLC
Morehead City, North Carolina, United States, 28557
Actively Recruiting
60
Shelby Clinical Research, LLC - North Carolina
Shelby, North Carolina, United States, 28150
Actively Recruiting
61
Hometown Urgent Care and Research - Dayton
Dayton, Ohio, United States, 45424
Actively Recruiting
62
Delricht Research - Concierge Medicine Of Cincinnati
Mason, Ohio, United States, 45040
Withdrawn
63
DelRicht Research - Tulsa
Tulsa, Oklahoma, United States, 74133
Withdrawn
64
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
65
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, United States, 19380
Withdrawn
66
Coastal Carolina Research Center - Main
North Charleston, South Carolina, United States, 29405
Actively Recruiting
67
Health Concepts
Rapid City, South Dakota, United States, 57702
Actively Recruiting
68
DelRicht Research - Hendersonville
Hendersonville, Tennessee, United States, 37075
Withdrawn
69
Zenos Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
70
Lone Star Arthritis & Rheumatology Associates - Denton
Denton, Texas, United States, 76205
Actively Recruiting
71
Epic Medical Research - DeSoto
DeSoto, Texas, United States, 75115
Actively Recruiting
72
Prolato Clinical Research Center
Houston, Texas, United States, 77027
Actively Recruiting
73
Pioneer Research Solutions
Houston, Texas, United States, 77099
Actively Recruiting
74
R & H Clinical Research - Westborough Drive
Katy, Texas, United States, 77449
Actively Recruiting
75
Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville, Texas, United States, 75057
Actively Recruiting
76
Southwest Rheumatology Research
Mesquite, Texas, United States, 75150
Actively Recruiting
77
Discovery Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
78
ERG - Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
Actively Recruiting
79
DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas, United States, 77375
Actively Recruiting
80
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Actively Recruiting
81
Centrum Medyczne Solumed
Poznan, Greater Poland Voivodeship, Poland, 60-529
Actively Recruiting
82
FutureMeds - Krakow
Krakow, Lesser Poland Voivodeship, Poland, 31-501
Actively Recruiting
83
FutureMeds - Wroclaw
Wroclaw, Lower Silesian Voivodeship, Poland, 53-673
Actively Recruiting
84
Innova Clinic
Plońsk, Masovian Voivodeship, Poland, 09-100
Actively Recruiting
85
Prolato Clinical Research Center
Sochaczew, Masovian Voivodeship, Poland, 96-500
Actively Recruiting
86
Medicover Integrated Clinical Services- MICS Centrum Medyczne Warszawa Chlodna
Warsaw, Masovian Voivodeship, Poland, 00-872
Actively Recruiting
87
FutureMeds - Targówek
Warsaw, Masovian Voivodeship, Poland, 03-291
Actively Recruiting
88
Inter Clinic
Bialystok, Podlaskie Voivodeship, Poland, 15-077
Actively Recruiting
89
ClinicMed Daniluk, Nowak Spółka Komandytowa
Bialystok, Podlaskie Voivodeship, Poland, 15-879
Actively Recruiting
90
FutureMeds Gdynia
Gdynia, Pomeranian Voivodeship, Poland, 81-537
Actively Recruiting
91
Med-Progress Ośrodek Nowoczesnego Leczenia
Wejherowo, Pomeranian Voivodeship, Poland, 84-200
Actively Recruiting
92
Pro Familia - Katowice
Katowice, Silesian Voivodeship, Poland, 40-122
Actively Recruiting
93
Silmedic sp. z o.o.
Katowice, Silesian Voivodeship, Poland, 40-282
Actively Recruiting
94
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
Actively Recruiting
95
Clínica Gaias Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Actively Recruiting
96
Accellacare - Alcobendas
Alcobendas, Madrid, Spain, 28100
Actively Recruiting
97
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain, 28032
Actively Recruiting
98
Hospital Quirónsalud Infanta Luisa
Seville, Sevilla, Spain, 41010
Actively Recruiting
99
Clínica NTDE - Nuevas Tecnologías en Diabetes y Endocrinología
Seville, Sevilla, Spain, 46010
Actively Recruiting
100
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
Research Team
C
Clinical Trial Lead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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