Clinical Trials for Gout

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Gout from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 17
• Active, not recruiting: 5
• Completed: 16
• Other: 12

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT05109936 — Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration

Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (> 360umol / l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. It appears in the form of spontaneously regressive inflammatory joint attacks in 5 to 7 days but recurrent. Gout turns into a chronic disease if uric acidemia is not reduced, and is r…

NCT07504146 — The Orienting Study

This study at IRCCS Galeazzi - Sant’Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessi…

NCT06880653 — Dose Response of Exercise for Arthritis Management

The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.

NCT05507723 — Tight Control of Gouty Arthritis Compared to Usual Care

Gout is caused by a reaction to urate crystals that results in attacks of severe joint pain. Medicines that lower urate levels can prevent gout flares, however it takes time for this benefit to be felt, and paradoxically starting treatment with large doses of urate lowering treatment risks provoking attacks of gout. Medical guidelines disagree on the best way to overcome these challenges with m…

NCT07089875 — A Study of Dotinurad Versus Allopurinol in Participants With Gout

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.

NCT07089888 — A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

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 tophaceous gout.

NCT06622603 — the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More

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 t…

NCT07141888 — The Effects of a Probiotic Food Supplement in Hyperuricaemia

The overall aim of the project is to determine whether a daily intake of health-promoting bacteria, known as probiotics, with or without a dietary fiber, affects uric acid levels in individuals with elevated levels of uric acid in the blood (hyperuricemia). Additionally, the project will investigate which individuals benefit from this dietary supplement and which do not, based on factors such a…

NCT07280156 — A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)

This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the respective placebos in adult patients with gout.

NCT07367971 — Drug-Drug Interaction Study of ABP-671 in Gout Patients

This is a open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients. Pharmacokinetic (PK) interaction between ABP-671 and Allopurinol will be evaluated in participants who are on stable Allopurinol therapy.

NCT07388498 — A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout

The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6.

NCT07362355 — The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia

SHR4640 tablets is a highly selective and potent URAT1 inhibitors. The study is being conducted to evaluate the efficacy, and safety of SHR4640 tablet combined with 40 mg/d febuxostat tablet in reducing uric acid in subjects with primary gout and hyperuricemia The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and 40 mg/d febuxostat compared wi…

NCT07414394 — Tigulixostat (IBI128) vs Febuxostat in Gout

The primary purpose of this study is to compare the efficacy of Tigulixostat (IBI128) versus Febuxostat on the proportion of Chinese adults with gout achieving a serum uric acid (sUA) level < 360 μmol/L at Week 24. The study also evaluates safety, gout attacks, kidney function, inflammation, and quality of life over 52 weeks of treatment. Approximately 600 eligible participants will be randomi…

NCT07490522 — The Remote Monitoring of Gout Feasibility Study in Primary Care

The goal of this feasibility study is to determine the feasibility of a patient self-management app (MinUrinsyregikt) for patients with gout. The primary objectives of the study are:

1. To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up.
2. To determine the feasibility of conducting a future randomised controlled trial to test the effect…

NCT07535034 — A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants

The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.

NCT06674109 — SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial

SAVE-Care (Sodium Glucose Cotransporter-2 inhibitors [SGLT2i] As Novel Gout Care) Trial is a double-blind randomized placebo-controlled trial (RCT) designed to assess the effect of empagliflozin on serum urate [SU] levels of gout patients, as well as levels of highly-sensitivity C-reactive protein [hsCRP] and interleukin 6 [IL-6], and estimate gout flares over 3 months, in order to deve…

NCT07613138 — Tart Cherry Citrate Effervescent Tablet for Urate-Lowering Therapy in Participants With Asymptomatic Hyperuricemia

The goal of this clinical trial is to learn whether tart cherry citrate effervescent tablets can lower uric acid levels in people with asymptomatic hyperuricemia (high uric acid levels without gout symptoms).

The main question it aims to answer is:

Does taking tart cherry citrate effervescent tablets lower uric acid levels more effectively than taking a placebo (inactive) tablet, when both gr…

Active, Not Recruiting

NCT04075903 — Gout in the ED and Improving Research Participation

The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel emergency department led intervention we aim to improve the care patients with gout receive, both during acute exacerbations an…

NCT06846515 — Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

NCT07004231 — Using Gout Buddy to Enhance Gout Management

Background: Dietary management is crucial for gout, but patients often lack adequate dietary literacy. However, patients often lack adequate dietary literacy and struggle to navigate complex dietary recommendations. Gout Buddy is an autonomous AI agent to offer personalized gout education and awareness tailored to individual needs. This study aims to evaluate the effectiveness and user experien…

NCT07116746 — Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase). Failed uricase treatment is defined as having an inherent intolerance, anaphylaxis, infusion reaction, antibody development, and/or at least one sUA level that rose to greater than 6 mg/dL while on therapy.

NCT07295496 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare (Part B)

Not Yet Recruiting

NCT07498647 — Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia

This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in subjects with primary gout and hyperuricemia.

This study is a dose exploration study, including a screening period (up to 2 weeks), a double-blind treatment period (1…

NCT07613164 — Probiotic-Uricase Complex Preparation for Improving Uric Acid Metabolism in Patients With Hyperuricemia

This single-center, open-label, two-arm interventional study aims to evaluate the efficacy and safety of a probiotic-uricase complex preparation in patients with hyperuricemia. Participants aged 18 to 60 years with hyperuricemia will be assigned to either the intervention group or the control group. Participants in the intervention group will receive the probiotic-uricase complex preparation du…

NCT07587684 — A Study of IN026 in Participants With Refractory Gout

The goal of this clinical study is to learn if IN026 Injection is safe and works to lower uric acid levels in adults with refractory gout (gout that does not respond well to standard treatments). The main questions it aims to answer are:

• What medical problems do participants have when taking IN026, such as changes in vital signs, blood tests, or heart rhythm?
• How does the body absorb, proc…

NCT07616531 — Efficacy and Safety of Scheduled Versus As-Needed Firsekibart Administration for the Prevention of Gout Recurrence: A Multicenter, Open-Label, Randomized Controlled Trial

Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart.

Primary Endpoint The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.

Secondary Endpoints The mean number of gout recurrences within 2…

NCT07625514 — 24-Week Recurrence Rate of Gout Following Firsekibart Treatment

Study Objective: To evaluate the 24-week recurrence rate and safety of Firsekibart in patients with acute gouty arthritis in a real-world clinical setting.

Study Methods: This study utilizes a multicenter, prospective, observational, real-world study design. The study plans to enroll all cases that receive Firsekibart for the first time and meet the inclusion and exclusion criteria between Mar…

NCT07657156 — Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis

Rheumatoid arthritis (RA) and gouty arthritis (GA) are two common forms of joint inflammation that can present with very similar physical symptoms, making them difficult to tell apart early in the disease process. Accurate and early differentiation is crucial because the treatment strategies and long-term management for the two conditions are substantially different.

The primary purpose of thi…

NCT07346027 — Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects

The study is to evaluate the impact of food on the pharmacokinetics of F-02-2-Na in healthy adult subjects by observing the changes in the drug’s pharmacokinetic profile-particularly in its absorption process-before and after food intake.

NCT07661030 — The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time

To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.

Enrolling by Invitation

NCT07324434 — A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects

The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of ascending single orally administered doses of F-02-2-Na in adult subjects (to include the Mass Balance) & multiple orally administered doses of F-02-2-Na in adult subjects with Hyperuricemia.

Completed Trials

NCT07546643 — Long-Term Risk of Gout in Living Kidney Donors

This population-based, matched, retrospective cohort study will evaluate the long-term risk of gout among living kidney donors compared with matched healthy nondonors, using linked administrative health care databases from Ontario, Alberta, and British Columbia. Living kidney donors who donated between 1992 and 2024 will be identified and matched 1:10 to a carefully selected population of healt…

NCT04849312 — Prediction of 30-Day Readmission Using Machine Learning

This is a retrospective observational study drawing on data from the Brigham and Women’s Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict the likelihood of 30-day readmission throughout a patient’s admission. This algorithm was then validated in a validation cohort.

NCT03162341 — Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit

The objective of this research is to evaluate the correlation between DECT and US explorations performed in a routine clinical setting for the measurement of change in tophus size in gout patients after 24 months of treatment.

NCT01867840 — Role of ASICs in Human Inflammatory Pain

In recent years, ion channels have emerged as new therapeutic targets for pain. Among these channels, ASICs (Acid Sensing Ion Channels) are of particular interest because they are directly activated by extracellular acidity, which is a major cause of pain. Indeed, many painful conditions such as ischemia, inflammation, tumor development or tissue incision are accompanied by tissue acidification…

NCT05925166 — Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein in the Treatment of Acute Gout

The goal of this study is to evaluate the efficacy and safety of Recombinant Human Tumor necrosis Factor-α Receptor Ⅱ Fusion Protein （rhTNFR-Fc）in the treatment of patients with acute Gout.

NCT04762498 — A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)

This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combination with weekly oral doses of methotrexate (MTX). The goal is to identify an appropriate dose to b…

NCT05045742 — Prediction of Patient Deterioration Using Machine Learning

This is a retrospective observational study drawing on data from the Brigham and Women’s Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict patient deterioration throughout a patient’s admission. This algorithm was then validated in a validation cohort.

NCT04812886 — Epidemiology of Gout in French Polynesia

Gout is a chronic disease caused by the deposit of monosodium urate (MSU) crystals in body tissues secondary to hyperuricemia. Patients with gout suffer severe attacks of acute joint pain. As the disease progresses, the joint pain becomes chronic and associated with disabling and deformative manifestations called tophi. Gout is strongly associated with various comorbidities including cardiovasc…

NCT04900090 — Tahiti-families: Polynesian Families of Gout Patients

Gout is a chronic disease caused by the deposit of monosodium urate (MSU) crystals in body tissues secondary to hyperuricemia. Patients with gout suffer severe attacks of acute joint pain. As the disease progresses, the joint pain becomes chronic and associated with disabling and deformative manifestations called tophus. This disease is strongly associated with several comorbidities such as car…

NCT05127772 — A Clinical Trial of HEC93077 in Chinese Healthy Subjects and HUA Patients With Single or Multiple Dosing

A phase 1 clinical trial of HEC93077,to evaluate the safety ,PK,PD and food effect in Chinese healthy subjects and HUA patients after single or multiple dosing.

NCT06969469 — To Evaluate the Influence of (LUA Probiotics) on Uric Acid

This study aims to investigate the efficacy of the lactic acid bacteria “LUA probiotics” in reducing serum uric acid levels. The use of health supplements prior to the onset of gout symptoms is proposed as a preventive strategy to mitigate the development of gout and to reduce the subsequent reliance on long-term pharmacological treatments. Hyperuricemia is the presence of abnormally high level…

NCT05815901 — A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.

NCT06056570 — Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia

A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to evaluate the effect of dotinurad, as monotherapy and in combination with allopurinol, versus allopurinol monotherapy, on the PK of each, and to assess the additive PD effec…

NCT06229145 — A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout.

The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX…

NCT06439602 — Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

NCT06444867 — A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 158968

The main objective of the study is to evaluate the effect on pain of a single, subcutaneous (SC) dose of LEO 158968 in participants with gout flares.

Other (Withdrawn)

NCT07493798 — Serum Potassium Prediction Using Machine Learning and Single-lead ECG

This is a retrospective study drawing on data from the Brigham and Women’s Hospital Home Hospital Program’s Database. Sociodemographic and clinical data from a training cohort were used to train a machine learning algorithm to predict blood potassium throughout a patient’s admission. This algorithm was then validated in a validation cohort.

NCT04784351 — Prediction of Expected Length of Hospital Stay Using Machine Learning

This is a retrospective observational study drawing on data from the Brigham and Women’s Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict length of stay throughout a patient’s admission. This algorithm was then validated in a validation cohort.

Other (Terminated)

NCT05698680 — Prednisolone Versus Colchicine for Acute Gout in Primary Care

Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribed for pain relief during an acute gout attack. However to date, no direct comparison of efficacy of colchicine and prednisolone for the treatment of acute gout attacks has been investigate…