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

A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02290210

Enrollment

Registered

2014-11-14

Start date

2014-07-24

Completion date

2015-08-31

Last updated

2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout, Hyperuricemia

Brief summary

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

Interventions

DRUGURC102 0.25mg

DRUGURC102 0.5mg

DRUGURC102 1.0mg

DRUGURC102 2.0mg

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 70 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Trend of serum uric acid reduction and trend of serum uric acid levels	weekly for 3weeks	Frequency of patients with serum uric acid level reduced to \< 6.0 mg/dL and \< 5.0 mg/dL at each measurement

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026