NCT04804111

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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-finding Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of URC102 in Patient With Gout

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Placebo-controlled, randomized, double-blind, multicenter, phase 2 clinical trial.

Conditions

• Gout

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-21
• Primary completion: 2020-09-04
• Completion: 2020-11-29
• First posted: 2021-03-18
• Last updated: 2021-03-18

Locations

2 sites across 1 country: South Korea