Gout Clinical Trial
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
| Verified date | January 2022 |
| Source | LG Chem |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 156 |
| Est. completion date | May 17, 2021 |
| Est. primary completion date | May 3, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Synexus Clinical Research | Akron | Ohio |
| United States | Synexus Clinical Research | Anderson | South Carolina |
| United States | Avant Research Associates | Austin | Texas |
| United States | Synexus Clinical Research | Birmingham | Alabama |
| United States | Synexus Clinical Research | Chandler | Arizona |
| United States | OnSite Clinical Solutions | Charlotte | North Carolina |
| United States | OnSite Clinical Solutions | Charlotte | North Carolina |
| United States | Synexus Clinical Research | Chicago | Illinois |
| United States | Synexus Clinical Research | Cincinnati | Ohio |
| United States | IACT Health | Columbus | Georgia |
| United States | Synexus Clinical Research | Columbus | Ohio |
| United States | Synexus Clinical Research | Dallas | Texas |
| United States | Altoona Center For Clinical Research | Duncansville | Pennsylvania |
| United States | Synexus Clinical Research | Henderson | Nevada |
| United States | Discovery MM Services Incorporated | Houston | Texas |
| United States | Health Awareness Inc | Jupiter | Florida |
| United States | Preferred Research Partner | Little Rock | Arkansas |
| United States | Meridien Research | Maitland | Florida |
| United States | Synexus Clinical Research | Mesa | Arizona |
| United States | Miami Dade Medical Research Institute | Miami | Florida |
| United States | Paramount Medical Research and Consulting | Middleburg Heights | Ohio |
| United States | Olive Branch Family Medical Cente | Olive Branch | Mississippi |
| United States | Quality Clinical Research | Omaha | Nebraska |
| United States | Synexus Clinical Research | Omaha | Nebraska |
| United States | Synexus Clinical Research | Richfield | Minnesota |
| United States | Dominion Medical Associates | Richmond | Virginia |
| United States | Synexus Clinical Research | Saint Louis | Missouri |
| United States | Meridien Research | Saint Petersburg | Florida |
| United States | Synexus Clinical Research | Salt Lake City | Utah |
| United States | Synexus Clinical Research | San Antonio | Texas |
| United States | Avita Clinical Trials | Tampa | Florida |
| United States | Clinical Research Trials of Florida, Inc | Tampa | Florida |
| United States | Synexus Clinical Research | Tucson | Arizona |
| United States | Advanced Clinical Research | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| LG Chem |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | sUA level | Proportion of subjects with sUA <5.0 mg/dL | Day 84 | |
| Secondary | sUA level | Proportion of subjects with sUA <6.0 mg/dL | Day 84 | |
| Secondary | Pharmacokinetic | Ctrough,ss | baseline, Day 7, Day 28 and Day 56 | |
| Secondary | Pharmacodynamic | Change and percent change in sUA levels | Up to Day 84 | |
| Secondary | Pharmacodynamic | Maximum percent reduction in sUA level | Up to Day 84 | |
| Secondary | Antiflare activity | Gout flare rate in subjects | Up to Day 84 |
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