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Completed

NCT Number: NCT02557126

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

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

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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–69 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

Drug

Placebo

Drug

Primary outcomes

  1. Trend of serum uric acid reduction rate (%)

    Time frame: 2 weeks

  2. Trend of serum uric acid levels (mg/dL)

    Time frame: 2 weeks

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
2015
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2015
Registry last updated
Jan 10, 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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