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

Phase 2

Completed

• Conditions: Gout; Hyperuricemia
• Interventions: Drug: Placebo; Drug: URC102

• Registration Number: NCT02557126
• Lead Sponsor: JW Pharmaceutical

Brief Summary

The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate Lowering Effect of URC102 in gout patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2015-10
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

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
URC102	URC102	URC102

Primary Outcome Measures

Name	Time	Method
Trend of serum uric acid reduction rate (%)	2 weeks
Trend of serum uric acid levels (mg/dL)	2 weeks

Trial Locations

Locations (1)

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