search
Back to results

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

Primary Purpose

Gout, Hyperuricemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LC350189 formulated capsule
Placebo
Sponsored by
LG Chem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Synexus Clinical Research
  • Synexus Clinical Research
  • Synexus Clinical Research
  • Synexus Clinical Research
  • Preferred Research Partner
  • Health Awareness Inc
  • Meridien Research
  • Miami Dade Medical Research Institute
  • Meridien Research
  • Clinical Research Trials of Florida, Inc
  • Avita Clinical Trials
  • IACT Health
  • Synexus Clinical Research
  • Synexus Clinical Research
  • Olive Branch Family Medical Cente
  • Synexus Clinical Research
  • Quality Clinical Research
  • Synexus Clinical Research
  • Synexus Clinical Research
  • OnSite Clinical Solutions
  • OnSite Clinical Solutions
  • Synexus Clinical Research
  • Synexus Clinical Research
  • Synexus Clinical Research
  • Paramount Medical Research and Consulting
  • Altoona Center For Clinical Research
  • Synexus Clinical Research
  • Avant Research Associates
  • Synexus Clinical Research
  • Discovery MM Services Incorporated
  • Synexus Clinical Research
  • Synexus Clinical Research
  • Advanced Clinical Research
  • Dominion Medical Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

LC350189 50mg

LC350189 100mg

LC350189 200mg

Placebo

Arm Description

LC350189 50mg, Once a day (QD)

LC350189 100mg, QD

LC350189 200mg, QD

Placebo, QD

Outcomes

Primary Outcome Measures

sUA level
Proportion of subjects with sUA <5.0 mg/dL

Secondary Outcome Measures

sUA level
Proportion of subjects with sUA <6.0 mg/dL
Pharmacokinetic
Ctrough,ss
Pharmacodynamic
Change and percent change in sUA levels
Pharmacodynamic
Maximum percent reduction in sUA level
Antiflare activity
Gout flare rate in subjects

Full Information

First Posted
April 25, 2019
Last Updated
January 11, 2022
Sponsor
LG Chem
search

1. Study Identification

Unique Protocol Identification Number
NCT03934099
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
May 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LC350189 50mg
Arm Type
Experimental
Arm Description
LC350189 50mg, Once a day (QD)
Arm Title
LC350189 100mg
Arm Type
Experimental
Arm Description
LC350189 100mg, QD
Arm Title
LC350189 200mg
Arm Type
Experimental
Arm Description
LC350189 200mg, QD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, QD
Intervention Type
Drug
Intervention Name(s)
LC350189 formulated capsule
Intervention Description
Xanthine Oxidase Inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
sUA level
Description
Proportion of subjects with sUA <5.0 mg/dL
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
sUA level
Description
Proportion of subjects with sUA <6.0 mg/dL
Time Frame
Day 84
Title
Pharmacokinetic
Description
Ctrough,ss
Time Frame
baseline, Day 7, Day 28 and Day 56
Title
Pharmacodynamic
Description
Change and percent change in sUA levels
Time Frame
Up to Day 84
Title
Pharmacodynamic
Description
Maximum percent reduction in sUA level
Time Frame
Up to Day 84
Title
Antiflare activity
Description
Gout flare rate in subjects
Time Frame
Up to Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miyoung Kim, MD
Organizational Affiliation
LG Chem, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Synexus Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Synexus Clinical Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Synexus Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Synexus Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Preferred Research Partner
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Health Awareness Inc
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Miami Dade Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Avita Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Synexus Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Synexus Clinical Research
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
Country
United States
Facility Name
Olive Branch Family Medical Cente
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Synexus Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Synexus Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Synexus Clinical Research
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
OnSite Clinical Solutions
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Facility Name
OnSite Clinical Solutions
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Synexus Clinical Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Synexus Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Synexus Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Paramount Medical Research and Consulting
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Synexus Clinical Research
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Avant Research Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Synexus Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Discovery MM Services Incorporated
City
Houston
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Synexus Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Dominion Medical Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs