View clinical trials related to Gout.
Filter by:This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose regimens of ABP-671 compared with placebo. The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing. Each dose group will have 3 stages following screening: Run-in, Dose Evaluation, and Follow-up.
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
A web-based descriptive survey was conducted among doctors with regular interaction with gout patients. The questionnaire comprised of 38 multiple choice questions; 9 questions for demographic data, 8, 11 and 10 questions each for knowledge, attitude and practice, respectively. Simple descriptive statistics were used to describe the correct responses.
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy will be performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.
The objective of the Urica Cor Intervention (URICORI) trial is to evaluate the effectiveness of a one-year, intervention of modifiable risk factors for CVD administered in a rheumatology outpatient clinical setting, compared with conventional treatment for modifiable risk factors for CVD in people with gout.
Background: Hospitalized patients usually have significant comorbidities and receive multiple medications which leads to a high frequency of contraindications to standard treatment options for acute gout (NSAIDs, colchicine, steroids). Adrenocorticotropic hormone (ACTH) has long been used in acute gout, exhibiting significant clinical efficacy and an excellent safety profile. Aim: To assess 1) the clinical efficacy of ACTH in gout compared to betamethasone in hospitalized patients 2) the safety profile of ACTH vs betamethasone and 3) the effect of ACTH on immune responses and metabolic parameters. Methods: This is a randomized, open label comparative study directly comparing ACTH vs betamethasone for acute gout. The investigators plan to recruit 60 hospitalized patients who will be randomly assigned to either the ACTH or the betamethasone group on a 1:1 basis. Participants will be clinically assessed at baseline and at 24, 48, 72h and 5 days time points. (Intensity of pain, physician and patient global assessment, tenderness, swelling and redness). Serum and plasma samples will be collected at baseline and at the 24, 48, 72h time points from all study paticipants. The investigators will assess the effect of ACTH vs betamethasone on several metabolic parameters concentrating on glucose homeostasis. Results: The study is currently recruiting patients. Conclusions: If the efficacy and safety profile of ACTH is verified in this randomized controlled trial, the use of ACTH for the treatment of gout in the hospital setting will be strongly supported.
This is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with approximately 240 mL of water. Each period will be separated by a washout interval of 4 days.
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
Gout is a kind of crystal-associated arthropathy caused by monosodium urate deposition, which is directly related to hyperuricemia caused by purine metabolic disorder and/or decreased uric acid excretion. It belongs to the category of metabolic rheumatism. Gout can be complicated with kidney disease. The severe cases can occur joint destruction, renal function damage, and often accompanied by hyperlipidemia, hypertension, diabetes, arteriosclerosis and coronary heart disease and so on. The prevalence of gout varies greatly from different countries. But on the whole, the prevalence of gout is increasing year by year, and the incidence of gout is getting younger. With the continuous improvement of living standards in today's society, middle-aged men have quietly become a high incidence group of gout. The pathophysiological basis of gout is hyperuricemia, so reducing uric acid is the core of gout treatment. The reducing uric acid in patients with gout is a long-term process, and the drug can not be stopped after the serum uric acid is reduced to normal. Once patients with gout stop taking uric acid-lowering drugs, serum uric acid quickly returns to the pre-treatment level, which can not only cause gout attack again, but also bring the risk of kidney and cardio-cerebrovascular involvement if serum uric acid does not reach the control standard for a long time. Therefore, uric acid-lowering therapy requires the use of a minimum dose of uric acid-lowering drugs to maintain long-term uric acid levels. In recent years, with the aggravation of environmental pollution and the postponement of childbearing age, the incidence of male infertility is increasing year by year. However, there are relatively few studies on the effect of gout caused by hyperuricemia on male sperm quality. With the rejuvenation of gout patients and the long-term nature of uric acid-lowering therapy, the safety of uric acid-lowering drugs in male gout patients of childbearing age during pregnancy is not sure. Coupled with the opening of China's comprehensive second-child policy, more and more male gout patients join this fertility group. Unfortunately, so far, no animal or human trial has observed the effect of uric acid-lowering drugs on sperm quality. For this reason, this study intends to carry out this observational clinical trial to evaluate the effect of long-term use of uric acid-lowering drugs on male sperm quality by collecting relevant data of patients with gout treated with uric acid-lowering drugs. Aim to provide a theoretical basis for the safety of uric acid-lowering drugs during pregnancy.