A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03934099
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

LG Chem
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gout, Hyperuricemia
Arms & Interventions

Arms

Experimental: LC350189 50mg

LC350189 50mg, QD

Experimental: LC350189 100mg

LC350189 100mg, QD

Experimental: LC350189 200mg

LC350189 200mg, QD

Placebo Comparator: Placebo

Placebo, QD

Interventions

Drug: - Xanthine Oxidase Inhibitor

Test drug

Drug: - Placebo

Matching placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Synexus Clinical Research, Birmingham, Alabama

Status

Recruiting

Address

Synexus Clinical Research

Birmingham, Alabama, 35211

Synexus Clinical Research, Chandler, Arizona

Status

Recruiting

Address

Synexus Clinical Research

Chandler, Arizona, 85224

Synexus Clinical Research, Mesa, Arizona

Status

Recruiting

Address

Synexus Clinical Research

Mesa, Arizona, 85206

Synexus Clinical Research, Tucson, Arizona

Status

Recruiting

Address

Synexus Clinical Research

Tucson, Arizona, 85712

Preferred Research Partner, Little Rock, Arkansas

Status

Recruiting

Address

Preferred Research Partner

Little Rock, Arkansas, 72211

Health Awareness Inc, Jupiter, Florida

Status

Recruiting

Address

Health Awareness Inc

Jupiter, Florida, 33458

Meridien Research, Maitland, Florida

Status

Recruiting

Address

Meridien Research

Maitland, Florida, 32751

Miami Dade Medical Research Institute, Miami, Florida

Status

Recruiting

Address

Miami Dade Medical Research Institute

Miami, Florida, 33176

Meridien Research, Saint Petersburg, Florida

Status

Recruiting

Address

Meridien Research

Saint Petersburg, Florida, 33709

Clinical Research Trials of Florida, Inc, Tampa, Florida

Status

Recruiting

Address

Clinical Research Trials of Florida, Inc

Tampa, Florida, 33607

Avita Clinical Trials, Tampa, Florida

Status

Recruiting

Address

Avita Clinical Trials

Tampa, Florida, 33613

IACT Health, Columbus, Georgia

Status

Recruiting

Address

IACT Health

Columbus, Georgia, 31904

Synexus Clinical Research, Chicago, Illinois

Status

Recruiting

Address

Synexus Clinical Research

Chicago, Illinois, 60602

Synexus Clinical Research, Richfield, Minnesota

Status

Recruiting

Address

Synexus Clinical Research

Richfield, Minnesota, 55423

Olive Branch Family Medical Cente, Olive Branch, Mississippi

Status

Recruiting

Address

Olive Branch Family Medical Cente

Olive Branch, Mississippi, 38654

Synexus Clinical Research, Saint Louis, Missouri

Status

Recruiting

Address

Synexus Clinical Research

Saint Louis, Missouri, 63141

Quality Clinical Research, Omaha, Nebraska

Status

Recruiting

Address

Quality Clinical Research

Omaha, Nebraska, 68114

Synexus Clinical Research, Omaha, Nebraska

Status

Recruiting

Address

Synexus Clinical Research

Omaha, Nebraska, 68144

Synexus Clinical Research, Henderson, Nevada

Status

Recruiting

Address

Synexus Clinical Research

Henderson, Nevada, 89052

OnSite Clinical Solutions, Charlotte, North Carolina

Status

Recruiting

Address

OnSite Clinical Solutions

Charlotte, North Carolina, 28226

OnSite Clinical Solutions, Charlotte, North Carolina

Status

Recruiting

Address

OnSite Clinical Solutions

Charlotte, North Carolina, 28277

Synexus Clinical Research, Akron, Ohio

Status

Recruiting

Address

Synexus Clinical Research

Akron, Ohio, 44311

Synexus Clinical Research, Cincinnati, Ohio

Status

Recruiting

Address

Synexus Clinical Research

Cincinnati, Ohio, 45236

Synexus Clinical Research, Columbus, Ohio

Status

Recruiting

Address

Synexus Clinical Research

Columbus, Ohio, 43212

Middleburg Heights, Ohio

Status

Recruiting

Address

Paramount Medical Research and Consulting

Middleburg Heights, Ohio, 44130

Altoona Center For Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

Synexus Clinical Research, Anderson, South Carolina

Status

Recruiting

Address

Synexus Clinical Research

Anderson, South Carolina, 29621

Avant Research Associates, Austin, Texas

Status

Recruiting

Address

Avant Research Associates

Austin, Texas, 78704

Synexus Clinical Research, Dallas, Texas

Status

Recruiting

Address

Synexus Clinical Research

Dallas, Texas, 75234

Discovery MM Services Incorporated, Houston, Texas

Status

Recruiting

Address

Discovery MM Services Incorporated

Houston, Texas, 77450

Synexus Clinical Research, San Antonio, Texas

Status

Recruiting

Address

Synexus Clinical Research

San Antonio, Texas, 78229

Synexus Clinical Research, Salt Lake City, Utah

Status

Recruiting

Address

Synexus Clinical Research

Salt Lake City, Utah, 84123

Advanced Clinical Research, West Jordan, Utah

Status

Recruiting

Address

Advanced Clinical Research

West Jordan, Utah, 84088

Dominion Medical Associates, Richmond, Virginia

Status

Recruiting

Address

Dominion Medical Associates

Richmond, Virginia, 23219