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

No results posted yet for this study

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

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804111 on ClinicalTrials.gov