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

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ClinicalTrials.gov Identifier: NCT03372200
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Fuji Yakuhin Co., Ltd.
Information provided by (Responsible Party):
Mochida Pharmaceutical Company, Ltd.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

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

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




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



Information from the National Library of Medicine

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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

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


Contacts
Contact: Kazuki Furuno +81-3-3225-6332 kazuki.furuno@mochida.co.jp

Locations
Japan
Mochida Investigational sites Recruiting
Tokyo, Japan
Sponsors and Collaborators
Mochida Pharmaceutical Company, Ltd.
Fuji Yakuhin Co., Ltd.
Investigators
Study Director: Kazuki Furuno Clinical Research Department

Responsible Party: Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier: NCT03372200     History of Changes
Other Study ID Numbers: FYU-981-014
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Febuxostat
Gout Suppressants
Antirheumatic Agents