Gout Clinical Trial
Living with Gout?
Gout flares are not only painful but also can be very frustrating. This is because many people with gout continue to have painful flares even though they are taking their medication as directed. This study is evaluating the effectiveness of the study drug, dotinurad, which is already approved in China and Japan, compared to other gout medicine in lowering serum uric acid (the waste product that builds up in the blood, leading to gout symptoms).
What Are The Gout Clinical Trials?
There are 2 studies for people with different forms of gout:
- The RUBY Study, for people with gout who have been taking the same dose of their usual gout medicine for at least 3 months, with at least 2 relapses in the last 12 months.
- The TOPAZ Study is for people with tophaceous gout, a severe form of the disease that is chronic, and difficult to control. In addition, people with this form of gout develop “tophi,” lumps under the skin of the hands or feet resulting from uric acid crystal accumulation.
Participate in one of our Gout Clinical trials!
Participants will receive:
The study drug, dotinurad, or other study-supplied gout medicine
Medication to prevent gout flares
Monitoring by the study team throughout the study
Reimbursement for reasonable study-related expenses (travel and meals)
The Gout Clinical Trials
- Each of the clinical studies are slightly different. The specific treatment plans, number of study visits, and tests and assessments a study participant will have varies, based on which clinical study they are involved in. Both require:
- 18 to 75 years old (male or female)
- Have been diagnosed with gout for at least 1 year
- Have taken the same dose of your usual gout medicine for at least 3 months prior to entering this study
- You will need to meet other requirements to join the RUBY and TOPAZ Studies. Please contact us for details.
Why Join Us?
There are many reasons to take part in clinical research.
- For starters, it allows participants to play a more proactive role in their own health by receiving a new treatment for an ongoing disease or condition. Participants also play an important part in bringing much needed drugs to market, benefitting thousands of people who also have the disease or condition. In many cases, this can be life-changing. In addition to benefitting those with the disease, participants may be paid for their time and travel expenses.
- Clinical research studies (also called clinical trials) are carefully supervised research that is done before an investigational drug becomes available to the public
- Clinical studies follow specific rules to protect the safety, rights, well-being, and privacy of participants.
- The results help doctors and researchers decide if a medication or product is safe and should be available to patients.
- Clinical studies are an important way to develop new medical treatments to improve patient care.
Participants like you really help make a difference.
Expertise and Resources
We have the necessary tools to conduct clinical research on new as well as previously studied medications.
Commitment and Dedication
We have more than 30 years of experience providing high-quality patient care with the pharmaceutical industry.
Wide Range of Studies
We have offered more than 200 clinical research studies pioneered by medical experts in Bradenton Research Center.
Gout--Prevention and Treatment
If you are eligible to take part, you may have the following procedures done to check your health: vital signs, blood work, physical exams, or other types of assessments that are necessary to gather the required information about the study medication.
Both of these studies are double-blinded. That means that neither you nor the study doctor will know whether you are taking dotinurad or your usual gout medicine during the study treatment period. Blinding is a process common in clinical trials to help determine that the data are not biased, and are therefore more reliable.
In some other some clinical trials, you may not receive the study medication, but instead receive a placebo. A placebo looks like the study drug and is given the same way, but has no active medication. For this study, you will at least be on your usual gout medicine.
All study volunteers are always closely watched by clinic staff and the medical team to ensure their safety.