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

LG Chem

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia; Gout

Treatments: Drug: LC350189 formulated capsule; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03934099

LG-GDCL002

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 4 patient groups, including a placebo group

LC350189 50mg

Experimental group

Description:

LC350189 50mg, Once a day (QD)

Treatment:

Drug: LC350189 formulated capsule

LC350189 100mg

Experimental group

Description:

LC350189 100mg, QD

Treatment:

Drug: LC350189 formulated capsule

LC350189 200mg

Experimental group

Description:

LC350189 200mg, QD

Treatment:

Drug: LC350189 formulated capsule

Placebo

Placebo Comparator group

Description:

Placebo, QD

Treatment:

Drug: Placebo