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CompletedNCT02290210Updated Mar 8, 2017

Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients

A Phase 2 interventional study of URC102 0.25mg and URC102 0.5mg in Gout and Hyperuricemia, sponsored by JW Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-08.

Sponsored by JW Pharmaceutical · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2014, registered Nov 2014).
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Gout
  • Hyperuricemia

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03

In context

Gout

232 studies on the registry are indexed under Gout; 45 are open to participants now.

This study's enrollment of 64 is below the median of 121 across 202 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

JW Pharmaceutical is the lead sponsor of 75 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with gout

Exclusion criteria

Exclusion Criteria:

  • Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo x 2weeks

    Drug: placebo

  • Placebo comparator
    URC102 0.25mg

    0.25mg URC102 x 2weeks

    Drug: URC102 0.25mg

  • Experimental
    URC102 0.5mg

    0.5mg URC102 x 2weeks

    Drug: URC102 0.5mg

  • Placebo comparator
    URC102 1.0mg

    1.0mg URC102 x 2weeks

    Drug: URC102 1.0mg

  • Placebo comparator
    URC102 2.0mg

    2.0mg URC102 x 2weeks

    Drug: URC102 2.0mg

Interventions

  • DrugURC102 0.25mg
  • DrugURC102 0.5mg
  • DrugURC102 1.0mg
  • DrugURC102 2.0mg
  • Drugplacebo
06

What researchers measure

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

    Time frame: weekly for 3weeks

07

Study locations

1 site
  • JW Pharmaceutical
    Seoul, Seocho-dong 137-864, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02290210
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Nov 14, 2014
Start date
Jul 24, 2014
Primary completion
Dec 2, 2014
Completion
Aug 31, 2015
Last update
Mar 8, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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