Exploratory Study on the Treatment of Gout With Potassium Citrate Sustained-release Tablets
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHuashan Hospital
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium Bicarbonate Oral Capsule
DrugOn the basis of the standard uric acid-lowering treatment plan, sodium bicarbonate should be taken three times a day, 1.0g each time
Potassium Citrate Tablets
DrugOn the basis of the standard uric acid-lowering treatment plan, potassium citrate was taken three times a day, 2.16g each time
uric-acid-lowering drug
DrugThe 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.
Treatment groups
312 Participants
are divided into 3 treatment groupsGroup A: Controll groupActive comparator 1 intervention
Group B: Potassium citrate groupExperimental treatment 2 interventions
Group C: Sodium bicarbonate groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
serum uric acid
Time frame
From enrollment to the end of treatment at 48 weeksSecondary outcomes
1
gout flare
Time frame
From enrollment to the end of treatment at 48 weeksOther outcomes
1
nephrolithiasis
Time frame
From enrollment to the end of treatment at 48 weeksSponsors and contacts
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Source ClinicalTrials.gov