Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients

JW Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia; Gout

Treatments: Drug: placebo; Drug: URC102 0.5mg; Drug: URC102 2.0mg; Drug: URC102 1.0mg; Drug: URC102 0.25mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02290210

URC102KR

Details and patient eligibility

About

The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia

Enrollment: 64 patients

Sex: Male

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with gout

Exclusion criteria

• Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo x 2weeks

Treatment:

Drug: placebo

URC102 0.25mg

Placebo Comparator group

Description:

0.25mg URC102 x 2weeks

Treatment:

Drug: URC102 0.25mg

URC102 0.5mg

Experimental group

Description:

0.5mg URC102 x 2weeks

Treatment:

Drug: URC102 0.5mg

URC102 1.0mg

Placebo Comparator group

Description:

1.0mg URC102 x 2weeks

Treatment:

Drug: URC102 1.0mg

URC102 2.0mg

Placebo Comparator group

Description:

2.0mg URC102 x 2weeks

Treatment:

Drug: URC102 2.0mg