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

Sponsor
LG Chem (Industry)
Overall Status
Completed
CT.gov ID
NCT03934099
Collaborator
(none)
156
Enrollment
34
Locations
4
Arms
17.5
Actual Duration (Months)
4.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: LC350189 formulated capsule
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
156 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 :
Dec 2, 2019
Actual Primary Completion Date :
May 3, 2021
Actual Study Completion Date :
May 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: LC350189 50mg

LC350189 50mg, Once a day (QD)

Drug: LC350189 formulated capsule
Xanthine Oxidase Inhibitor
Experimental: LC350189 100mg

LC350189 100mg, QD

Drug: LC350189 formulated capsule
Xanthine Oxidase Inhibitor
Experimental: LC350189 200mg

LC350189 200mg, QD

Drug: LC350189 formulated capsule
Xanthine Oxidase Inhibitor
Placebo Comparator: Placebo

Placebo, QD

Drug: Placebo
Matching placebo

Outcome Measures

Primary Outcome Measures

  1. sUA level [Day 84]

    Proportion of subjects with sUA <5.0 mg/dL

Secondary Outcome Measures

  1. sUA level [Day 84]

    Proportion of subjects with sUA <6.0 mg/dL

  2. Pharmacokinetic [baseline, Day 7, Day 28 and Day 56]

    Ctrough,ss

  3. Pharmacodynamic [Up to Day 84]

    Change and percent change in sUA levels

  4. Pharmacodynamic [Up to Day 84]

    Maximum percent reduction in sUA level

  5. Antiflare activity [Up to Day 84]

    Gout flare rate in subjects

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Synexus Clinical Research Birmingham Alabama United States 35211
2 Synexus Clinical Research Chandler Arizona United States 85224
3 Synexus Clinical Research Mesa Arizona United States 85206
4 Synexus Clinical Research Tucson Arizona United States 85712
5 Preferred Research Partner Little Rock Arkansas United States 72211
6 Health Awareness Inc Jupiter Florida United States 33458
7 Meridien Research Maitland Florida United States 32751
8 Miami Dade Medical Research Institute Miami Florida United States 33176
9 Meridien Research Saint Petersburg Florida United States 33709
10 Clinical Research Trials of Florida, Inc Tampa Florida United States 33607
11 Avita Clinical Trials Tampa Florida United States 33613
12 IACT Health Columbus Georgia United States 31904
13 Synexus Clinical Research Chicago Illinois United States 60602
14 Synexus Clinical Research Richfield Minnesota United States 55423
15 Olive Branch Family Medical Cente Olive Branch Mississippi United States 38654
16 Synexus Clinical Research Saint Louis Missouri United States 63141
17 Quality Clinical Research Omaha Nebraska United States 68114
18 Synexus Clinical Research Omaha Nebraska United States 68144
19 Synexus Clinical Research Henderson Nevada United States 89052
20 OnSite Clinical Solutions Charlotte North Carolina United States 28226
21 OnSite Clinical Solutions Charlotte North Carolina United States 28277
22 Synexus Clinical Research Akron Ohio United States 44311
23 Synexus Clinical Research Cincinnati Ohio United States 45236
24 Synexus Clinical Research Columbus Ohio United States 43212
25 Paramount Medical Research and Consulting Middleburg Heights Ohio United States 44130
26 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
27 Synexus Clinical Research Anderson South Carolina United States 29621
28 Avant Research Associates Austin Texas United States 78704
29 Synexus Clinical Research Dallas Texas United States 75234
30 Discovery MM Services Incorporated Houston Texas United States 77450
31 Synexus Clinical Research San Antonio Texas United States 78229
32 Synexus Clinical Research Salt Lake City Utah United States 84123
33 Advanced Clinical Research West Jordan Utah United States 84088
34 Dominion Medical Associates Richmond Virginia United States 23219

Sponsors and Collaborators

  • LG Chem

Investigators

  • Study Director: Miyoung Kim, MD, LG Chem, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LG Chem
ClinicalTrials.gov Identifier:
NCT03934099
Other Study ID Numbers:
  • LG-GDCL002
First Posted:
May 1, 2019
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Gout
Hyperuricemia

Study Results

No Results Posted as of Jan 13, 2022