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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934099
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
LG Chem

Brief Summary:
The aim of this 12-week randomized multicenter double-blind double-dummy parallel group placebo and active comparator-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.

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Drug: Xanthine Oxidase Inhibitor Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: LC350189 50mg
LC350189 50mg, QD
Drug: Xanthine Oxidase Inhibitor
Test drug
Other Name: LC350189 formulated capsule

Experimental: LC350189 100mg
LC350189 100mg, QD
Drug: Xanthine Oxidase Inhibitor
Test drug
Other Name: LC350189 formulated capsule

Experimental: LC350189 200mg
LC350189 200mg, QD
Drug: Xanthine Oxidase Inhibitor
Test drug
Other Name: LC350189 formulated capsule

Active Comparator: Febuxostat
Febuxostat 40mg or 80mg QD
Drug: Xanthine Oxidase Inhibitor
Active comparator
Other Name: Febuxostat (Uloric)

Placebo Comparator: Placebo
Placebo, QD
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. sUA level [ Time Frame: Day 84 ]
    Proportion of subjects with sUA <5.0 mg/dL


Secondary Outcome Measures :
  1. sUA level [ Time Frame: Day 84 ]
    Proportion of subjects with sUA <6.0 mg/dL

  2. Pharmacokinetic [ Time Frame: baseline, Day 7, Day 28 and Day 56 ]
    Ctrough,ss

  3. Pharmacodynamic [ Time Frame: Up to Day 84 ]
    Change and percent change in sUA levels

  4. Pharmacodynamic [ Time Frame: Up to Day 84 ]
    Maximum percent reduction in sUA level

  5. Antiflare activity [ Time Frame: Up to Day 84 ]
    Gout flare rate in subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934099


Contacts
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Contact: Jieun Lee +82-2-6987-4156 jieunl@lgchem.com

Locations
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Sponsors and Collaborators
LG Chem

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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT03934099    
Other Study ID Numbers: LG-GDCL002
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gout
Hyperuricemia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes
Febuxostat
Gout Suppressants
Antirheumatic Agents