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Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372200
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : September 24, 2018
Sponsor:
Collaborator:
Fuji Yakuhin Co., Ltd.
Information provided by (Responsible Party):
Mochida Pharmaceutical Company, Ltd.

Study Description
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Brief Summary:
FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.

Condition or disease Intervention/treatment Phase
Hyperuricemia With or Without Gout Drug: FYU-981 Drug: Febuxostat Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : July 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Febuxostat

Arms and Interventions
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Arm Intervention/treatment
Experimental: FYU-981 Drug: FYU-981
Oral daily dosing for 14 weeks
Active Comparator: Febuxostat Drug: Febuxostat
Oral daily dosing for 14 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Percent reduction from baseline in serum urate level at the final visit [ Time Frame: 14 weeks ]
    Percent reduction from baseline in serum urate level at the final visit


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serum urate level:

    • >= 7.0mg/dL in patients with gouty nodule or with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
  • Disease type in the classification of hyperuricemia: Uric acid-underexcretion type or mixed type
  • Outpatients

Exclusion Criteria:

  • Gouty arthritis within 14 days before randomized allocation
  • Secondary hyperuricemia
  • HbA1c: >= 8.4%
  • Clinically significant cardiac, hepatic, renal, hematologic or endocrine disease
  • Kidney calculi or clinically significant urinary calculi
  • AST: >= 100 IU/L or ALT: >= 100 IU/L
  • eGFR: < 30 mL/min/1.73m^2
  • Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg
Contacts and Locations
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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): NCT03372200


Locations
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Japan
Mochida Investigational sites
Tokyo, Japan
Sponsors and Collaborators
Mochida Pharmaceutical Company, Ltd.
Fuji Yakuhin Co., Ltd.
Investigators
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Study Director: Kazuki Furuno Clinical Research Department
More Information
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Responsible Party: Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier: NCT03372200    
Other Study ID Numbers: FYU-981-014
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Febuxostat
Dotinurad
Gout Suppressants
Antirheumatic Agents
Uricosuric Agents
Renal Agents