A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
- Conditions
- GoutHyperuricemia
- Interventions
- Drug: LC350189 formulated capsuleDrug: Placebo
- Registration Number
- NCT03934099
- Lead Sponsor
- LG Chem
- Brief Summary
The aim of this 12-week randomized multicenter double-blind parallel group placebo-controlled dose finding study is to assess the efficacy and safety of three different doses of LC350189 in subjects with hyperuricemia and a diagnosis of gout.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- Subjects or the subject's legally acceptable representatives who sign a written informed consent form prior to the initiation of any study procedures.
- Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology (ACR) criteria.
- Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder, or organ transplant).
- Subjects experiencing an active acute gout attack within 3 weeks prior to screening (Visit 1).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LC350189 100mg LC350189 formulated capsule LC350189 100mg, QD LC350189 200mg LC350189 formulated capsule LC350189 200mg, QD LC350189 50mg LC350189 formulated capsule LC350189 50mg, Once a day (QD) Placebo Placebo Placebo, QD
- Primary Outcome Measures
Name Time Method sUA level Day 84 Proportion of subjects with sUA \<5.0 mg/dL
- Secondary Outcome Measures
Name Time Method sUA level Day 84 Proportion of subjects with sUA \<6.0 mg/dL
Pharmacokinetic baseline, Day 7, Day 28 and Day 56 Ctrough,ss
Pharmacodynamic Up to Day 84 Maximum percent reduction in sUA level
Antiflare activity Up to Day 84 Gout flare rate in subjects
Related Research Topics
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Trial Locations
- Locations (17)
Synexus Clinical Research
🇺🇸Salt Lake City, Utah, United States
Preferred Research Partner
🇺🇸Little Rock, Arkansas, United States
Health Awareness Inc
🇺🇸Jupiter, Florida, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Miami Dade Medical Research Institute
🇺🇸Miami, Florida, United States
Clinical Research Trials of Florida, Inc
🇺🇸Tampa, Florida, United States
Avita Clinical Trials
🇺🇸Tampa, Florida, United States
IACT Health
🇺🇸Columbus, Georgia, United States
Olive Branch Family Medical Cente
🇺🇸Olive Branch, Mississippi, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
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