Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets

Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets (NCT06966635) is a Phase 4 interventional studying Hyperuricemia or Gout and Nephrolithiasis, sponsored by Huashan Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

To evaluate whether alkalization has the effect of lowering uric acid and reducing gout flare and determine whether alkalization has a role in the prevention and treatment of urinary calculi in gout, the research participants were divided into the control group, the potassium citrate group and the sodium bicarbonate group. 2 alkalization groups took potassium citrate three times a day 2.16g each time, or sodium bicarbonate three times a day, 1.0g each time, on the basis of the standard uric acid-lowering treatment plan. The control group was treated with the standard uric acid-lowering treatment regimen alone. Uric acid-lowering treatment plan: Maintain the individualized uric acid-lowering treatment plan at the time of patient enrollment. Traditional uric acid-lowering treatment plans include drugs that reduce uric acid production such as febuxostat and allopurinol, and drugs that increase uric acid excretion such as benzbromarone. At the time of enrollment, the uric acid-lowering drugs were stable.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 312 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - Meet the diagnostic criteria of the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) for gout in 2015 - Age 18-70 years old, gender is not limited - The interval between the most recent acute onset of gout is at least \> 2 weeks - Routine treatment with stable dose of uric-lowering drugs for \> 4 weeks - For women who are likely to become pregnant, pregnancy tests must be negative, they must not be lactating, they must be using an investigator-approved method of contraception, and they must agree to maintain this method of contraception throughout the study - Study participants were informed, voluntarily signed willing to sign a consent form, and agreed to participate in all visits, examinations, and treatments as required by the trial protocol - willing to sign a consent form to the purpose and content of the research. Who Should NOT Join This Trial: - Acute gout flare - Secondary gout caused by kidney disease, blood disease, or taking certain drugs, tumor radiotherapy and chemotherapy - Severe and unstable cardiovascular and cerebrovascular diseases (such as unstable angina pectoris, coronary angiogenesis, cerebral angiogenesis, transient ischemic attack, congestive heart failure, etc.), acute and difficult to control diseases, chronic diffuse connective tissue disease, xanthine urethral deposition, Lesch-Nyhan syndrome, untreated thyroid disease or kidney stones, treatment Patients with severe hypertension (blood pressure \> 160/100mmHg) or diabetes (fasting blood glucose \> 11.1mmol/L) and organ transplantation that were not effectively controlled later - People who are allergic, have a history of allergy to test-related drugs (febuxosita tablets, allopurinol tablets, benzbromarone, etoracoxib, colchicine, potassium citrate, etc.) or are allergic to test-related drug components ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Meet the diagnostic criteria of the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) for gout in 2015 * Age 18-70 years old, gender is not limited * The interval between the most recent acute onset of gout is at least \> 2 weeks * Routine treatment with stable dose of uric-lowering drugs for \> 4 weeks * For women who are likely to become pregnant, pregnancy tests must be negative, they must not be lactating, they must be using an investigator-approved method of contraception, and they must agree to maintain this method of contraception throughout the study * Study participants were informed, voluntarily signed informed consent, and agreed to participate in all visits, examinations, and treatments as required by the trial protocol * Informed consent to the purpose and content of the research. Exclusion Criteria: * Acute gout flare * Secondary gout caused by kidney disease, blood disease, or taking certain drugs, tumor radiotherapy and chemotherapy * Severe and unstable cardiovascular and cerebrovascular diseases (such as unstable angina pectoris, coronary angiogenesis, cerebral angiogenesis, transient ischemic attack, congestive heart failure, etc.), acute and difficult to control diseases, chronic diffuse connective tissue disease, xanthine urethral deposition, Lesch-Nyhan syndrome, untreated thyroid disease or kidney stones, treatment Patients with severe hypertension (blood pressure \> 160/100mmHg) or diabetes (fasting blood glucose \> 11.1mmol/L) and organ transplantation that were not effectively controlled later * People who are allergic, have a history of allergy to test-related drugs (febuxosita tablets, allopurinol tablets, benzbromarone, etoracoxib, colchicine, potassium citrate, etc.) or are allergic to test-related drug components * Active peptic ulcer or ulcer with bleeding and perforation, severe chronic diarrhea or recurrent skin disease in the past year * Blood white blood cell count \< 3.0x109/L, hemoglobin \< 90g/L, platelet count \< 100x109/L, or other blood system diseases (such as severe anemia, idiopathic thrombocytopenic purpura, spleen enlargement, coagulation dysfunction, etc.) * Active stage of liver disease or abnormal liver function (ALT or AST≥2 times the upper limit of normal) * Patients with abnormal renal function (eGFR≤60ml/min/1.73m\^2) * Patients with elevated blood potassium (5.5mmol/L) may have diseases or factors that may lead to hyperkalemia, such as type IV renal tubular acidosis and widespread tissue injury * Urine PH value \> 6.5 during screening * Combined use of the following drugs: Contains salicylate drugs such as aspirin (\> 300mg/d), thiazide diuretics, potassium diuretics such as amphenopterine, Amiloride, ACEI, azathioprine, 6-mercaptopurine, theophylline, losartan, cyclosporin A, cyclophospfamide, pyrazinamide, glucocorticoid (except in acute episodes), Niergoline tablets, long-term use of insulin, Digitalis * Women who are pregnant, planning to become pregnant or breastfeeding mental illness, no self-knowledge, unable to accurately express or can not take drugs on time * A history of alcohol abuse or dependence on known drugs within the last two years * Those who have participated or are participating in other clinical trials within three months * The study participant is a family member or relative of the staff of the research Center * Other lesions or conditions that, in the investigator's judgment, reduce or complicate enrollment.

Treatments Being Tested

DRUG

Sodium Bicarbonate Oral Capsule

On the basis of the standard uric acid-lowering treatment plan, sodium bicarbonate should be taken three times a day, 1.0g each time

DRUG

Potassium Citrate Tablets

On the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time

DRUG

uric-acid-lowering drug

The control group was treated with the standard uric acid-lowering treatment regimen alone. Uric acid-lowering treatment plan: Maintain the individualized uric acid-lowering treatment plan at the time of patient enrollment. Traditional uric acid-lowering treatment plans include drugs that reduce uric acid production such as febuxostat and allopurinol, and drugs that increase uric acid excretion such as benzbromarone. At the time of enrollment, the uric acid-lowering drugs were stable. The treatment plan for lowering uric acid remained unchanged for 4 weeks after enrollment in the clinical study until the endpoint.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Huashan hospital, Fudan university

Shanghai, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06966635), the sponsor (Huashan Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06966635 clinical trial studying?

To evaluate whether alkalization has the effect of lowering uric acid and reducing gout flare and determine whether alkalization has a role in the prevention and treatment of urinary calculi in gout, the research participants were divided into the control group, the potassium citrate group and the sodium bicarbonate group. 2 alkalization groups took potassium citrate three times a day 2.16g each time, or sodium bicarbonate three times a day, 1.0g each time, on the basis of the standard uric acid-lowering treatment plan. The control group was treated with the standard uric acid-lowering treatme… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06966635?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06966635?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06966635. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06966635. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.