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

Phase 2

Completed

• Conditions: Gout; Hyperuricemia
• Interventions: Drug: LC350189 formulated capsule; Drug: Placebo

• Registration Number: NCT03934099
• Lead Sponsor: LG Chem

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Study Start: 2019-12-02
• Primary Completion: 2021-05-03
• Study Completion: 2021-05-17
• Status Verified: 2022-01
• Disposition First Submitted: 2022-01-10
• Disposition First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Disposition First Posted: 2022-01-13
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LC350189 100mg	LC350189 formulated capsule	LC350189 100mg, QD
LC350189 200mg	LC350189 formulated capsule	LC350189 200mg, QD
LC350189 50mg	LC350189 formulated capsule	LC350189 50mg, Once a day (QD)
Placebo	Placebo	Placebo, QD

Primary Outcome Measures

Name	Time	Method
sUA level	Day 84	Proportion of subjects with sUA \<5.0 mg/dL

Secondary Outcome Measures

Name	Time	Method
sUA level	Day 84	Proportion of subjects with sUA \<6.0 mg/dL
Pharmacokinetic	baseline, Day 7, Day 28 and Day 56	Ctrough,ss
Pharmacodynamic	Up to Day 84	Maximum percent reduction in sUA level
Antiflare activity	Up to Day 84	Gout flare rate in subjects

Trial Locations

Locations (17)

Avita Clinical Trials; 🇺🇸 Tampa, Florida, United States

Meridien Research; 🇺🇸 Saint Petersburg, Florida, United States

IACT Health; 🇺🇸 Columbus, Georgia, United States

Olive Branch Family Medical Cente; 🇺🇸 Olive Branch, Mississippi, United States

Dominion Medical Associates; 🇺🇸 Richmond, Virginia, United States

Synexus Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Preferred Research Partner; 🇺🇸 Little Rock, Arkansas, United States

Health Awareness Inc; 🇺🇸 Jupiter, Florida, United States

Altoona Center For Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Clinical Research Trials of Florida, Inc; 🇺🇸 Tampa, Florida, United States

Paramount Medical Research and Consulting; 🇺🇸 Middleburg Heights, Ohio, United States

Avant Research Associates; 🇺🇸 Austin, Texas, United States

OnSite Clinical Solutions; 🇺🇸 Charlotte, North Carolina, United States

Advanced Clinical Research; 🇺🇸 West Jordan, Utah, United States

Miami Dade Medical Research Institute; 🇺🇸 Miami, Florida, United States

Quality Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Discovery MM Services Incorporated; 🇺🇸 Houston, Texas, United States