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NCT02557126 Clinical Trial

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

Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02557126
Other study ID # URC103KR
Secondary ID
Status Completed
Phase Phase 2
First received September 16, 2015
Last updated January 9, 2017
Start date October 2015
Est. completion date August 2016

Study information
Verified date January 2017
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 69 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• URC102

• Placebo

Locations
Country Name City State
Korea, Republic of JW Pharmaceutical Seoul Seocho-dong

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Trend of serum uric acid reduction rate (%) 2 weeks No
Primary Trend of serum uric acid levels (mg/dL) 2 weeks No
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