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Completed

NCT Number: NCT02290210

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

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

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

JW Pharmaceutical

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with gout

Exclusion criteria

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

Treatment and study plan

URC102 0.25mg

Drug

URC102 0.5mg

Drug

URC102 1.0mg

Drug

URC102 2.0mg

Drug

Placebo

Drug

Primary outcomes

  1. Trend of serum uric acid reduction and trend of serum uric acid levels

    Time frame: weekly for 3weeks

    Frequency of patients with serum uric acid level reduced to < 6.0 mg/dL and < 5.0 mg/dL at each measurement

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Nov 14, 2014
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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