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

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 54

Inclusion Criteria

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
this study

Exclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of acute gout attacks (excluding gout precursors) during treatment period (first 24 weeks of study)

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale, VAS;Number of gout attacks per patient during treatment period (first 24 weeks of study) ;Incidence of gout attacks (excluding gout precursors) during monitoring period.;Proportion of patients with gout attacks requiring rescue therapy between weeks 24 and 36 ;Incidence of proportion of patients with serum uric acid levels below 6.0 mg/dL during monitoring period.;Time required to serum uric acid levels below 6.0 mg/d