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

Hyperuricemia With or Without Gout Clinical Trial

Official title:

Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375632
• Other study ID #: FYU-981-013
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2018
• Est. completion date: June 5, 2018

Study information

• Verified date: September 2018
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 5, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gout
• Hyperuricemia
• Hyperuricemia With or Without Gout

Intervention

Drug:
• FYU-981
Oral daily dosing for 14 weeks

Locations

Country	Name	City	State
Japan	Mochida Investigational sites	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.	Fuji Yakuhin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics (Amount of uric acid excreted in urine)		2-week
Primary	Pharmacodynamics (Amount of uric acid excreted in urine)		6-week
Primary	Pharmacodynamics (Amount of uric acid excreted in urine)		10-week
Primary	Pharmacodynamics (Amount of uric acid excreted in urine)		14-week