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New treatment option for Hyperuricemia or Gout
Official title Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets
ClinicalTrials.gov ID: NCT06966635
What this study is testing
What is Sodium Bicarbonate Oral Capsule?
Sodium Bicarbonate Oral Capsule is an investigational medicine, being studied as a potential treatment for hyperuricemia or gout.
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
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
You likely can't join if
- 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...
- People who are allergic, have a history of allergy to test-related drugs (febuxosita tablets, allopurinol tablets, benzbromarone, etoracoxib...
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. 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.