A Multi-center, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Efficacy and Safety of Diacerein for Prophylaxis in Patients with Gout who Have Difficulties to Use Colchicine for Prophylaxis

Masan Samsung Medical Center0 个研究点目标入组 54 人开始时间: 待定最近更新: 2022年10月24日

试验速览

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•1. Person over 19 years old as of the date of submission
•2. Patients diagnosed with gout according to American College of Rheumatology (ACR) 1977 Criteria for the
•classification of acute arthritis of primary gout or 2015 ACR Gout classification Criteria
•3. Patient who have started or are about to start uric acid lowering treatment
•A. Allopurinol 50mg to 600mg/day
•B. Febuxostat 20mg to 80mg/day
•4. Patient who have the ability and willingness to participate in the therapeutic lifestyle modification
•recommended in this clinical trial
•5.Patient who have difficulty in using colchicine as a
•prophylaxis or have intolerance
•6.Patient who have difficulty using antiphlogistic for on
•of the following two reasons
•- GI intolerance
•- eGFR < 75 mL/min/1.73m2
•7.Persons who submitted written consent to participate in

•1.Patients with importance of hypersensitivity disease in clinical (etc.anaphylaxis)
•2.Patient with hypersensitivity to this drug or any component of this drug
•3.Patients with history of myocardial infarction or angina within 6 months or suspicious symptoms at screening
•4.Patients with abdominal pain of unknown
•5.Those with the following diseases or abnormal blood test
•- CKD stage 4 higher: eGFR < 30mL/min/1.73m2
•- AST or ALT = 2 x upper limit of normal (ULN) or
•total bilirubin = 1.5 x ULN
•- Uncontrolled diabetes mellitus: glycated hemoglobin
•(HbA1c) = 9.0% or
•fasting plasma glucose = 200 mg/dL
•- Uncontrolled hypertension: systolic blood pressure =
•180 mmHg or diastolic blood pressure = 110 mmHg Uncontrolled thyroid dysfunction: TSH = 1.5 x ULN
•Inflammatory bowel disease (ulcerative colitis, Crohn's
•disease) or irritable bowel syndrome
•- Patients have intestinal obstruction or have a history of
•paralytic ileus
•- History of intestinal disease in the small intestine
•- Patients have liver disease or history of liver disease
•6.patients with history of drug and alcohol abuse within 5 years
•7.Patients who have participated in other clinical trials within 3 months prior to screening and have applied
•investigational drugs
•8.Pregnant or lactating women or positive pregnancy test
•9.Other patients judged to be unsuitable by the investigator

发起方

Masan Samsung Medical Center