Clinical trial NCT03934099: A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
Official title: A Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group, Placebo and Active Comparator-controlled, Dose Finding, and Phase II Study to Assess Efficacy and Safety of LC350189 in Gout Patients With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Hyperuricemia
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-05-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Subjects or the subject's legally acceptable representatives who sign a written informed consent form prior to the initiation of any study procedures.
2. Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology (ACR) criteria.

Exclusion Criteria:

1. Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder, or organ transplant).
2. Subjects experiencing an active acute gout attack within 3 weeks prior to screening (Visit 1).

Primary outcomes:
measure: sUA level
timeFrame: Day 84
Secondary outcomes:
measure: sUA level
timeFrame: Day 84
measure: Pharmacokinetic
timeFrame: baseline, Day 7, Day 28 and Day 56
measure: Pharmacodynamic
timeFrame: Up to Day 84
measure: Pharmacodynamic
timeFrame: Up to Day 84
measure: Antiflare activity
timeFrame: Up to Day 84
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Synexus Clinical Research
state: Alabama
city: Chandler
country: United States
facility: Synexus Clinical Research
state: Arizona
city: Mesa
country: United States
facility: Synexus Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Synexus Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partner
state: Arkansas
city: Jupiter
country: United States
facility: Health Awareness Inc
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Trials
state: Florida
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Chicago
country: United States
facility: Synexus Clinical Research
state: Illinois
city: Richfield
country: United States
facility: Synexus Clinical Research
state: Minnesota
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Cente
state: Mississippi
city: Saint Louis
country: United States
facility: Synexus Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Synexus Clinical Research
state: Nebraska
city: Henderson
country: United States
facility: Synexus Clinical Research
state: Nevada
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Akron
country: United States
facility: Synexus Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Synexus Clinical Research
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research and Consulting
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Anderson
country: United States
facility: Synexus Clinical Research
state: South Carolina
city: Austin
country: United States
facility: Avant Research Associates
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research
state: Texas
city: Houston
country: United States
facility: Discovery MM Services Incorporated
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Synexus Clinical Research
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Richmond
country: United States
facility: Dominion Medical Associates
state: Virginia
Study officials:
affiliation: LG Chem, Ltd.
name: Miyoung Kim, MD
role: STUDY_DIRECTOR
References: