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

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ClinicalTrials.gov Identifier: NCT02290210
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Drug: URC102 0.25mg Drug: URC102 0.5mg Drug: URC102 1.0mg Drug: URC102 2.0mg Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 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
Actual Study Start Date : July 24, 2014
Actual Primary Completion Date : December 2, 2014
Actual Study Completion Date : August 31, 2015

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 70 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): NCT02290210


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

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Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT02290210     History of Changes
Other Study ID Numbers: URC102KR
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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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