- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03100318
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
September 24, 2018 updated by: Fuji Yakuhin Co., Ltd.
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan
- Tokyo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FYU-981
|
Oral daily dosing for 14 weeks
|
ACTIVE_COMPARATOR: Benzbromarone
|
Oral daily dosing for 14 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2017
Primary Completion (ACTUAL)
April 25, 2018
Study Completion (ACTUAL)
August 31, 2018
Study Registration Dates
First Submitted
March 29, 2017
First Submitted That Met QC Criteria
April 3, 2017
First Posted (ACTUAL)
April 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 26, 2018
Last Update Submitted That Met QC Criteria
September 24, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Metabolism, Inborn Errors
- Crystal Arthropathies
- Purine-Pyrimidine Metabolism, Inborn Errors
- Hyperuricemia
- Gout
- Antirheumatic Agents
- Gout Suppressants
- Renal Agents
- Uricosuric Agents
- Benzbromarone
- Dotinurad
Other Study ID Numbers
- FYU-981-011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Mochida Pharmaceutical Company, Ltd.Fuji Yakuhin Co., Ltd.CompletedHyperuricemia With or Without GoutJapan
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Fuji Yakuhin Co., Ltd.Mochida Pharmaceutical Company, Ltd.Completed
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Mochida Pharmaceutical Company, Ltd.Fuji Yakuhin Co., Ltd.CompletedHyperuricemia With or Without GoutJapan
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Clinical Trials on FYU-981
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Mochida Pharmaceutical Company, Ltd.Fuji Yakuhin Co., Ltd.Completed
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Fuji Yakuhin Co., Ltd.Completed
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Fuji Yakuhin Co., Ltd.Mochida Pharmaceutical Company, Ltd.Completed
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Eisai Co., Ltd.CompletedHealthy VolunteersChina
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Mochida Pharmaceutical Company, Ltd.Fuji Yakuhin Co., Ltd.CompletedHepatic Insufficiency | HealthyJapan
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Mochida Pharmaceutical Company, Ltd.Fuji Yakuhin Co., Ltd.CompletedHyperuricemia With or Without GoutJapan
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Fuji Yakuhin Co., Ltd.Completed
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Mochida Pharmaceutical Company, Ltd.Fuji Yakuhin Co., Ltd.CompletedHyperuricemia With or Without GoutJapan
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Fuji Yakuhin Co., Ltd.Mochida Pharmaceutical Company, Ltd.Completed