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

March 6, 2017 updated by: JW Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seocho-dong
      • Seoul, Seocho-dong, Korea, Republic of, 137-864
        • JW Pharmaceutical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo x 2weeks
Drug: placebo
Placebo Comparator: URC102 0.25mg
0.25mg URC102 x 2weeks
Drug: URC102 0.25mg
Experimental: URC102 0.5mg
0.5mg URC102 x 2weeks
Drug: URC102 0.5mg
Placebo Comparator: URC102 1.0mg
1.0mg URC102 x 2weeks
Drug: URC102 1.0mg
Placebo Comparator: URC102 2.0mg
2.0mg URC102 x 2weeks
Drug: URC102 2.0mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trend of serum uric acid reduction and trend of serum uric acid levels
Time Frame: 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
weekly for 3weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2014

Primary Completion (Actual)

December 2, 2014

Study Completion (Actual)

August 31, 2015

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URC102KR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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