Back to resultsPhase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients
Primary Purpose
Gout, Hyperuricemia
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
URC102 0.25mg
URC102 0.5mg
URC102 1.0mg
URC102 2.0mg
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 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Placebo
URC102 0.25mg
URC102 0.5mg
URC102 1.0mg
URC102 2.0mg
Arm Description
Placebo x 2weeks
0.25mg URC102 x 2weeks
0.5mg URC102 x 2weeks
1.0mg URC102 x 2weeks
2.0mg URC102 x 2weeks
Outcomes
Primary Outcome Measures
Trend of serum uric acid reduction and trend of serum uric acid levels
Frequency of patients with serum uric acid level reduced to < 6.0 mg/dL and < 5.0 mg/dL at each measurement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02290210
Brief Title
Phase 2 Study of URC102 to Assess the Efficacy and Safety 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
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 24, 2014 (Actual)
Primary Completion Date
December 2, 2014 (Actual)
Study Completion Date
August 31, 2015 (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, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia
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
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo x 2weeks
Arm Title
URC102 0.25mg
Arm Type
Placebo Comparator
Arm Description
0.25mg URC102 x 2weeks
Arm Title
URC102 0.5mg
Arm Type
Experimental
Arm Description
0.5mg URC102 x 2weeks
Arm Title
URC102 1.0mg
Arm Type
Placebo Comparator
Arm Description
1.0mg URC102 x 2weeks
Arm Title
URC102 2.0mg
Arm Type
Placebo Comparator
Arm Description
2.0mg URC102 x 2weeks
Intervention Type
Drug
Intervention Name(s)
URC102 0.25mg
Intervention Type
Drug
Intervention Name(s)
URC102 0.5mg
Intervention Type
Drug
Intervention Name(s)
URC102 1.0mg
Intervention Type
Drug
Intervention Name(s)
URC102 2.0mg
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Trend of serum uric acid reduction and trend of serum uric acid levels
Description
Frequency of patients with serum uric acid level reduced to < 6.0 mg/dL and < 5.0 mg/dL at each measurement
Time Frame
weekly for 3weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 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
Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients
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