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

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ClinicalTrials.gov Identifier: NCT02557126
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Drug: URC102 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients
Study Start Date : October 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: URC102
URC102
Drug: URC102
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557126


Locations
Korea, Republic of
JW Pharmaceutical
Seoul, Seocho-dong, Korea, Republic of, 137-864
Sponsors and Collaborators
JW Pharmaceutical

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT02557126     History of Changes
Other Study ID Numbers: URC103KR
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Gout
Hyperuricemia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes