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.
Placebo-controlled, randomized, double-blind, multicenter, phase 2 clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
171
JW Pharmaceutical
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Serum uric acid response rate (< 6.0 mg/dL) at week 4 after the IP administration.
Time frame: Week 4
Serum uric acid response rate (< 5.0 mg/dL) at week 4 after the IP administration.
Time frame: Week 4
Percent Change in Serum Uric Acid from Baseline to week 4
Time frame: Week 4
Change in Serum Uric Acid at week 4 from Baseline
Time frame: Week 4
The Incidence rate of gout attack from baseline to week 4
Time frame: week 4
Serum uric acid response rate(< 6.0 mg/dL) at week 8 and week 12 after the IP administration
Time frame: Week 8, Week 12
serum uric acid response rate(< 5.0 mg/dL) at week 8 and week 12 after the IP administration
Time frame: Week 8, Week 12
Percent Change in Serum Uric Acid from Baseline to week 8 and week 12
Time frame: Week 8, Week 12
Change in Serum Uric Acid at week 8 and 12 from Baseline
Time frame: Week 8, Week 12
The Incidence rate of gout attack from baseline to week 8 and 12
Time frame: Week 8, Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
9 mg of the URC102 group
Febuxostat 80 mg