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New treatment option for Gout
Official title the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More
ClinicalTrials.gov ID: NCT06622603
What this study is testing
What is Febuxostat?
Febuxostat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gout.
Also referred to as Usoric® Tab 40mg.
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 goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis) Researchers will compare three randomized groups: the reducing group takes febuxostat 20 mg once daily for 12 months, the discontinuing group takes a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months, and the maintaining group continues their pre-study urate-lowering agents for 12 months, serving as an observational reference group. During the 12-month study period, participants will visit every 3 months for laboratory evaluations including serum urate levels, and for checking symptomatic status using questionnaires and diaries.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 79
You may be able to join if
- 1. Adult gout patients aged ≥19 but \<80 years.
- Gout patients treated with urate-lowering therapy (either allopurinol or febuxostat monotherapy, or a combination of two agents) for at least the...
- Patients who have at least five serum urate level measurements over the past 5 years and meet one of the following criteria: All serum urate levels...
- Patients without palpable or visible tophi on physical examination (evaluated at pre-defined 18 joint sites and the ears).
- Patients without acute gouty attack or history of nephrolithiasis in the past 12 months
You likely can't join if
- people who continuously require prophylactic low-dose colchicine/NSAIDs.
- people already having taken low-dose urate-lowering agents. The low-dose urate-lowering agents are defined as allopurinol ≤200 mg/day or febuxostat...
- people taking medications that could affect serum uric acid levels and uric acid fractional excretion rates, such as benzbromarone, fenofibrate, loop...
- people classified as having high-risk alcohol use according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA): For men \<65 years...
- people with a history of hypersensitivity to febuxostat or allopurinol
- people with unstable cardiovascular conditions, who require adjustment of urgent their therapy
See the full eligibility criteria
- 1. Adult gout patients aged ≥19 but \<80 years.
- Gout patients treated with urate-lowering therapy (either allopurinol or febuxostat monotherapy, or a combination of two agents) for at least the past 5 years.
- Patients who have at least five serum urate level measurements over the past 5 years and meet one of the following criteria: All serum urate levels measured in the past 5 years have been maintained below 6.0 mg/dL; or...
- Patients without palpable or visible tophi on physical examination (evaluated at pre-defined 18 joint sites and the ears).
- Patients without acute gouty attack or history of nephrolithiasis in the past 12 months
- Patients with an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73m² or higher, based on the Cockcroft-Gault formula.
- Patients who voluntarily provide written informed consent to participate.
- people who continuously require prophylactic low-dose colchicine/NSAIDs.
- people already having taken low-dose urate-lowering agents. The low-dose urate-lowering agents are defined as allopurinol ≤200 mg/day or febuxostat ≤20 mg/day. But patients on a combination of low-dose allopurinol and...
- people taking medications that could affect serum uric acid levels and uric acid fractional excretion rates, such as benzbromarone, fenofibrate, loop diuretics, thiazide or thiazide-like diuretics, and losartan.
- people classified as having high-risk alcohol use according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA): For men \<65 years: more than 14 drinks per week or for men ≥65 years or women: more than 7...
- people with a history of hypersensitivity to febuxostat or allopurinol
- people with unstable cardiovascular conditions, who require adjustment of urgent their therapy
- people taking mercaptopurine or azathioprine
- people with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- people with moderate or severe liver dysfunction (AST or ALT levels greater than 3 times the upper normal limit)
- people for whom investigators anticipate that a change in a urate-lowering agent dose could present significant risks or that any factor could severely impact drug adherence, complicating study registration.
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Gyeonggi-do, South Korea
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, 19 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Gyeonggi-do, South Korea. 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.