Is Your Gout Under Control?
This study is exploring new options for gout management.
Why You Should Join
If you decide to take part, you will get:
- The study drug dotinurad
- Medication to prevent gout flares
- Study-related medical care throughout
the study - Compensation and reimbursement for study-related expenses (travel and meals)
A clinical trial is a carefully designed research study involving human volunteers to investigate the safety and effectiveness of a new drug or treatment. Clinical trials are essential for evaluating the benefits and risks of medical interventions, ultimately informing healthcare decisions and regulatory approvals.
As a clinical trial or observational study participant, your responsibilities and what you will be required to do can vary depending on the study, its objectives, and the phase of the trial.
Some common activities and responsibilities you may encounter as a participant include: diagnostic tests, treatments, procedures, doctor visits, dietary changes, exercise and/or other lifestyle changes. Observational studies often involve minimal effort, such as completing questionnaires, sharing test results, maintaining a diet or exercise log.
Joining a clinical trial can provide access to cutting-edge treatments, close medical monitoring, and an opportunity to contribute to medical knowledge. Participants may experience improved health outcomes and specialized care while potentially receiving compensation for volunteering.
Clinical trials are designed with a strong emphasis on the safety of participants, and multiple safeguards are in place to minimize risks, including careful study design, oversight by institutional review boards and routine monitoring of study data by independent experts. Researchers must inform participants of the risks, benefits and/or side effects they discover.
Yes, you can drop out of a clinical trial study at any time, and you have the right to do so without facing any penalties or consequences. This is often referred to as "withdrawal of consent."
Voluntary participation is a fundamental principle of clinical research. You are not obligated to continue in a trial if you no longer wish to do so.
Determining your eligibility to participate in a clinical trial involves a thorough evaluation of specific eligibility criteria set forth by the study's researchers and sponsors. The criteria help define the patient population being studied and are designed to protect the safety of participants in the trial.
Providing accurate information about your medical history and health status is crucial for your safety and the integrity of the research. If you are not eligible for one trial, you may still be eligible for other trials in the future, so it's worth exploring your options if you are interested in participating in clinical research.
Who Can Join
You may be able to join if you:
✅ Are 18 to 75 years of age
✅ Have been diagnosed with gout for at least 1 year
✅ Still have gout flare-ups and either:
*Are unable to take allopurinol or febuxostat
*OR− IV uricase treatment was not effective
*You will need to meet other requirements to join the study.
Not sure if you qualify? That’s okay.
A member of our recruitment team will review your medical history and medications with you to see if this study may be right for you.
About the Study
This study is testing the safety and effectiveness of dotinurad compared with a placebo at lowering serum uric acid—the waste product that causes gout symptoms—in people who still have flare-ups but CANNOT take allopurinol or febuxostat, or for whom intravenous (IV) uricase treatment did not help.
You will also be given colchicine or a nonsteroidal anti-inflammatory drug (NSAID) to prevent gout flares.
Joining this study is entirely voluntary (which means that participation is completely up to you). If you choose not to take part in this study, it will not impact your current medical care now or in the future. If you participate, you can decide to leave the study at any time and for any reason
