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

Phase 2

Completed

• Conditions: Gout; Hyperuricemia
• Interventions: Drug: placebo; Drug: URC102 0.25mg; Drug: URC102 0.5mg; Drug: URC102 1.0mg; Drug: URC102 2.0mg

• Registration Number: NCT02290210
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-24
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Primary Completion: 2014-12-02
• Study Completion: 2015-08-31
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo x 2weeks
URC102 0.25mg	URC102 0.25mg	0.25mg URC102 x 2weeks
URC102 0.5mg	URC102 0.5mg	0.5mg URC102 x 2weeks
URC102 1.0mg	URC102 1.0mg	1.0mg URC102 x 2weeks
URC102 2.0mg	URC102 2.0mg	2.0mg URC102 x 2weeks

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

JW Pharmaceutical; 🇰🇷 Seoul, Seocho-dong, Korea, Republic of