Back to resultsStudy of URC102 to Assess the Safety and Efficacy in Gout Patients
Primary Purpose
Gout, Hyperuricemia
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
URC102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
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)
Sites / Locations
- JW Pharmaceutical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
URC102
Placebo
Arm Description
URC102
Placebo
Outcomes
Primary Outcome Measures
Trend of serum uric acid reduction rate (%)
Trend of serum uric acid levels (mg/dL)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02557126
Brief Title
Study of URC102 to Assess the Safety and Efficacy in Gout Patients
Official Title
A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate Lowering Effect of URC102 in gout patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
URC102
Arm Type
Experimental
Arm Description
URC102
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
URC102
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Trend of serum uric acid reduction rate (%)
Time Frame
2 weeks
Title
Trend of serum uric acid levels (mg/dL)
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
JW Pharmaceutical
City
Seoul
State/Province
Seocho-dong
ZIP/Postal Code
137-864
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of URC102 to Assess the Safety and Efficacy in Gout Patients
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