ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03375632
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Fuji Yakuhin Co., Ltd.
Information provided by (Responsible Party):
Mochida Pharmaceutical Company, Ltd.

Brief Summary:
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.

Condition or disease Intervention/treatment Phase
Hyperuricemia With or Without Gout Drug: FYU-981 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout
Actual Study Start Date : January 4, 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

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

Experimental: Uric acid-underexcretion Type Drug: FYU-981
Oral daily dosing for 14 weeks




Primary Outcome Measures :
  1. Pharmacodynamics (Amount of uric acid excreted in urine) [ Time Frame: 2-week ]
  2. Pharmacodynamics (Amount of uric acid excreted in urine) [ Time Frame: 6-week ]
  3. Pharmacodynamics (Amount of uric acid excreted in urine) [ Time Frame: 10-week ]
  4. Pharmacodynamics (Amount of uric acid excreted in urine) [ Time Frame: 14-week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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-overproduction type or Uric acid-underexcretion type
  • Outpatients

Exclusion Criteria:

  • Gouty arthritis within 14 days before randomized allocation

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): NCT03375632


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: NCT03375632     History of Changes
Other Study ID Numbers: FYU-981-013
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs