NCT02557126

Brief Summary

The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate Lowering Effect of URC102 in gout patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2015

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

First Submitted

Initial submission to the registry

September 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

September 16, 2015

Last Update Submit

January 9, 2017

Conditions

GoutHyperuricemia

Outcome Measures

Primary Outcomes (2)

  • Trend of serum uric acid reduction rate (%)

    2 weeks

  • Trend of serum uric acid levels (mg/dL)

    2 weeks

Study Arms (2)

URC102

EXPERIMENTAL

URC102

Drug: URC102

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

URC102DRUG
URC102
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 69 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

September 16, 2015

First Posted

September 23, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

KR(1)