Study of of URC102 to Assess the Efficacy and Safety in Gout Patients
NCT04804111 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171
Last updated 2021-03-18
Summary
To confirm the safety and efficacy (dose response and optimal dose according to the serum uric acid response rate) of URC102 when orally-administered to patients with gout and gout-related hyperuricemia in comparison with placebo.
Therapeutic dose-finding study, Placebo-controlled, randomized, double-blind, multicenter, phase 2 clinical trial.
Conditions
Interventions
- DRUG
-
arm 0
placebo group
- DRUG
-
arm 1
3 mg of the URC102 group
- DRUG
-
arm 2
6 mg of the URC102 group
- DRUG
-
arm 3
9 mg of the URC102 group
- DRUG
-
arm 4
Febuxostat 80 mg
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-21
- Primary Completion
- 2020-09-04
- Completion
- 2020-11-29
Countries
- South Korea
Study Locations
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