Optimization of urate lowering therapy in Korean patients with gouty arthritis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0006930
- Lead Sponsor
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 305
1) Korean adult men and women aged 19 or older
2) At screening, patients diagnosed with acute gout according to 1977 American College of Rheumatology classification criteria for acute gout
3) Patients who need to start urate lowering therapy. The indications for urate lowering therapy as follows.
? have one or more tophis
? have acute gout flare more than once a year
? Gout arthritis on X-rays of the hands or feet
? when the physicians determines that urate lowering therapy is necessary
4) Patients who provided written informed consent for the clinical trial
1) Patients with ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, severe congestive heart failure patients and congestive heart failure patients (NYHA II~IV), uncontrolled hypertensive patients (SBP 180 mmHg or DBP 110 mmHg and above)
2) Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy, active peptic ulceration or bleeding
3) Patients with a history of cerebral hemorrhage or systemic bleeding, or with coagulation disorders or severe hematologic disorders
4) Individuals with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
5) Patients with inflammatory bowel diseases such as Crohn's disease or ulcerative colitis
6) Patients with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to urate-lowering therapies, such as colchicine, which are investigational drugs
7) Patients with a history of hypersensitivity reactions, asthma, rhinitis, nasal polyps, urticaria, allergic reactions to aspirin or other NSAIDs, or a history thereof
8) Pregnant or breastfeeding women, defined as women from the time of conception to the end of pregnancy, with a positive urine pregnancy test result. Also, those who do not consent to the use of appropriate contraceptive methods during the clinical trial period
9) For fertile women, those who do not agree to adhere to medically acceptable contraceptive methods for a minimum of 7 days during the clinical trial period and after the end of the trial
10) A patient who has received corticosteroids or urate-lowering medications (allopurinol, febuxostat, benzbromarone) within 4 weeks prior to screening
11) Individuals who have received or plan to receive mercaptopurine or azathioprine within 1 week or a period longer than 5 times the half-life from the screening
12) Patients with severe renal impairment (eGFR <50mL/min/1.73 m2)
13) Patients with severe hepatic impairment (AST, ALT, or total bilirubin levels greater than 3 times the upper limit of normal)
14) Patients who have participated in other clinical trial and have been exposed to investigational drugs or investigational medical devices within 4 weeks prior to screening
15) Individuals with a history of alcohol addiction or substance abuse within the past 5 years from the screening date
16) Individuals with clinically significant diseases, as determined by the investigator, that would warrant exclusion from this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in pain intensity (NRS) from baseline to W2
- Secondary Outcome Measures
Name Time Method Proportion of patients with complete pain relief (NRS 0 or 1) in W2 ;Time to complete pain relief (NRS 0 or 1);Change in pain intensity (NRS) from baseline to W6 and W12;number of daily use of rescue medication and proportion of patients using rescue medication;number of acute gout flare ;Erythrocyte sedimentation rate (ESR);C-reactive protein (CRP) or hs-CRP;Patient's global assessment;Quality of life;Compliance;Changes in serum uric acid levels ;Proportion of patients with serum uric acid levels below 6.0 mg/dL;Adverse event ;Laboratory test ;Physical examination;Vital sign