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Compares treatment options for Gout
Official title A Study of Dotinurad Versus Allopurinol in Participants With Gout
ClinicalTrials.gov ID: NCT07089875
What this study is testing
What is Allopurinol?
Allopurinol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gout.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Mesa, Arizona, United States
- Tucson, Arizona, United States
- Covina, California, United States
- Dublin, California, United States
- Norco, California, United States
- Northridge, California, United States
- Pomona, California, United States
- San Bernardino, California, United States
- San Diego, California, United States
- San Leandro, California, United States
- Spring Valley, California, United States
- Thousand Oaks, California, United States
- Tujunga, California, United States
- Denver, Colorado, United States
- Bradenton, Florida, United States
- Coral Gables, Florida, United States
- Hialeah, Florida, United States
+ 70 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States; Mesa, Arizona, United States; Tucson, Arizona, United States; Covina, California, United States and 84 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.