NCT02290210

Brief Summary

The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

November 4, 2014

Last Update Submit

March 6, 2017

Conditions

GoutHyperuricemia

Outcome Measures

Primary Outcomes (1)

  • 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

    weekly for 3weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo x 2weeks

Drug: placebo

URC102 0.25mg

PLACEBO COMPARATOR

0.25mg URC102 x 2weeks

Drug: URC102 0.25mg

URC102 0.5mg

EXPERIMENTAL

0.5mg URC102 x 2weeks

Drug: URC102 0.5mg

URC102 1.0mg

PLACEBO COMPARATOR

1.0mg URC102 x 2weeks

Drug: URC102 1.0mg

URC102 2.0mg

PLACEBO COMPARATOR

2.0mg URC102 x 2weeks

Drug: URC102 2.0mg

Interventions

URC102 0.25mgDRUG
URC102 0.25mg
URC102 0.5mgDRUG
URC102 0.5mg
URC102 1.0mgDRUG
URC102 1.0mg
URC102 2.0mgDRUG
URC102 2.0mg
placeboDRUG
Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with gout

You may not qualify if:

  • Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JW Pharmaceutical

Seoul, Seocho-dong, 137-864, South Korea

Location

MeSH Terms

Conditions

GoutHyperuricemia

Interventions

URC102

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 14, 2014

Study Start

July 24, 2014

Primary Completion

December 2, 2014

Study Completion

August 31, 2015

Last Updated

March 8, 2017

Record last verified: 2017-03

Locations

KR(1)