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

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ClinicalTrials.gov Identifier: NCT03100318
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Mochida Pharmaceutical Company, Ltd.
Information provided by (Responsible Party):
Fuji Yakuhin Co., Ltd.

Brief Summary:
FYU-981 or Benzbromarone are administrated to hyperuricemia patients 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: Benzbromarone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benzbromarone-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 : April 1, 2017
Actual Primary Completion Date : April 25, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: FYU-981 Drug: FYU-981
Oral daily dosing for 14 weeks

Active Comparator: Benzbromarone Drug: Benzbromarone
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:

  • Hyperuricemic or gout patients
  • Serum urate level:

>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL

Exclusion Criteria:

  • Gouty arthritis within two weeks before start of study treatment
  • Secondary hyperuricemia
  • HbA1c: >= 8.4%
  • Uric acid-overproduction type in the classification of hyperuricemia
  • History of, clinically significant cardiac, hematologic and hepatic disease
  • Kidney calculi or clinically significant urinary calculi
  • Hepatic dysfuction, or AST: >=100 IU/L or ALT: >=100 IU/L at the pre-examination
  • eGFR: < 30mL/min/1.73m^2
  • Systolic blood pressure: >= 180 mmHg
  • 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): NCT03100318


Locations
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Japan
Tokyo
Tokyo, Japan
Sponsors and Collaborators
Fuji Yakuhin Co., Ltd.
Mochida Pharmaceutical Company, Ltd.

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Responsible Party: Fuji Yakuhin Co., Ltd.
ClinicalTrials.gov Identifier: NCT03100318     History of Changes
Other Study ID Numbers: FYU-981-011
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 26, 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
Gout Suppressants
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
Benzbromarone
Uricosuric Agents
Antirheumatic Agents
Renal Agents