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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LC350189 50mg | Experimental | LC350189 50mg, Once a day (QD) |
|
| LC350189 100mg | Experimental | LC350189 100mg, QD |
|
| LC350189 200mg | Experimental | LC350189 200mg, QD |
|
| Placebo | Placebo Comparator | Placebo, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC350189 formulated capsule | Drug | Xanthine Oxidase Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 | sUA level was measured at Day 84 | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84 | sUA level was measured at Day 84 | Day 84 |
| Maximum Percent Reduction in sUA (Serum Uric Acid) Level | sUA level was measured at Day 1, 14, 28, 56, and 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyungjin Cho, MD | LG Chem, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus Clinical Research | Birmingham | Alabama | 35211 | United States | ||
| Synexus Clinical Research |
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Of the 156 participants enrolled, 13 were initially assigned to an active control group (Febuxostat) under the original protocol. This group was removed following a protocol amendment. Final results are reported based on the amended protocol, which excluded the active control group. Therefore, the discrepancy between the total number randomized and the final reported number reflects this change.
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| ID | Title | Description |
|---|---|---|
| FG000 | LC350189 50mg | LC350189 50mg, Once a day (QD) LC350189 formulated capsule: Xanthine Oxidase Inhibitor |
| FG001 | LC350189 100mg | LC350189 100mg, QD LC350189 formulated capsule: Xanthine Oxidase Inhibitor |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2020 | Oct 21, 2025 |
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| Placebo | Drug | Matching placebo |
|
| Up to Day 84 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Synexus Clinical Research | Mesa | Arizona | 85206 | United States |
| Synexus Clinical Research | Tucson | Arizona | 85712 | United States |
| Preferred Research Partner | Little Rock | Arkansas | 72211 | United States |
| Health Awareness Inc | Jupiter | Florida | 33458 | United States |
| Meridien Research | Maitland | Florida | 32751 | United States |
| Miami Dade Medical Research Institute | Miami | Florida | 33176 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Clinical Research Trials of Florida, Inc | Tampa | Florida | 33607 | United States |
| Avita Clinical Trials | Tampa | Florida | 33613 | United States |
| IACT Health | Columbus | Georgia | 31904 | United States |
| Synexus Clinical Research | Chicago | Illinois | 60602 | United States |
| Synexus Clinical Research | Richfield | Minnesota | 55423 | United States |
| Olive Branch Family Medical Cente | Olive Branch | Mississippi | 38654 | United States |
| Synexus Clinical Research | St Louis | Missouri | 63141 | United States |
| Quality Clinical Research | Omaha | Nebraska | 68114 | United States |
| Synexus Clinical Research | Omaha | Nebraska | 68144 | United States |
| Synexus Clinical Research | Henderson | Nevada | 89052 | United States |
| OnSite Clinical Solutions | Charlotte | North Carolina | 28226 | United States |
| OnSite Clinical Solutions | Charlotte | North Carolina | 28277 | United States |
| Synexus Clinical Research | Akron | Ohio | 44311 | United States |
| Synexus Clinical Research | Cincinnati | Ohio | 45236 | United States |
| Synexus Clinical Research | Columbus | Ohio | 43212 | United States |
| Paramount Medical Research and Consulting | Middleburg Heights | Ohio | 44130 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Synexus Clinical Research | Anderson | South Carolina | 29621 | United States |
| Avant Research Associates | Austin | Texas | 78704 | United States |
| Synexus Clinical Research | Dallas | Texas | 75234 | United States |
| Discovery MM Services Incorporated | Houston | Texas | 77450 | United States |
| Synexus Clinical Research | San Antonio | Texas | 78229 | United States |
| Synexus Clinical Research | Salt Lake City | Utah | 84123 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| Dominion Medical Associates | Richmond | Virginia | 23219 | United States |
| FG002 | LC350189 200mg | LC350189 200mg, QD LC350189 formulated capsule: Xanthine Oxidase Inhibitor |
| FG003 | Placebo | Placebo, QD Placebo: Matching placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LC350189 50mg | LC350189 50mg, Once a day (QD) LC350189 formulated capsule: Xanthine Oxidase Inhibitor |
| BG001 | LC350189 100mg | LC350189 100mg, QD LC350189 formulated capsule: Xanthine Oxidase Inhibitor |
| BG002 | LC350189 200mg | LC350189 200mg, QD LC350189 formulated capsule: Xanthine Oxidase Inhibitor |
| BG003 | Placebo | Placebo, QD Placebo: Matching placebo |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With sUA (Serum Uric Acid) < 5.0 mg/dL at Day 84 | sUA level was measured at Day 84 | Posted | Number | Percentage of participants | Day 84 |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With sUA (Serum Uric Acid) < 6.0 mg/dL at Day 84 | sUA level was measured at Day 84 | Posted | Number | Percentage of participants | Day 84 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Percent Reduction in sUA (Serum Uric Acid) Level | sUA level was measured at Day 1, 14, 28, 56, and 84 | Posted | Mean | Standard Deviation | Percentage of reduction in sUA | Up to Day 84 |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LC350189 50mg | LC350189 50mg, Once a day (QD) LC350189 formulated capsule: Xanthine Oxidase Inhibitor | 0 | 34 | 0 | 34 | 15 | 34 |
| EG001 | LC350189 100mg | LC350189 100mg, QD LC350189 formulated capsule: Xanthine Oxidase Inhibitor | 0 | 38 | 0 | 38 | 13 | 38 |
| EG002 | LC350189 200mg | LC350189 200mg, QD LC350189 formulated capsule: Xanthine Oxidase Inhibitor | 0 | 37 | 0 | 37 | 21 | 37 |
| EG003 | Placebo | Placebo, QD Placebo: Matching placebo | 0 | 34 | 0 | 34 | 8 | 34 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrehoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gout flare | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coronavirus test positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Younghwan Jang | LG Chem | 02-6987-4154 | younghj@lgchem.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2021 | Oct 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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