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

• Sponsor: Mochida Pharmaceutical Company, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03372200
• Collaborator: Fuji Yakuhin Co., Ltd. (Industry)
• Enrollment: 203
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site Per Month: 34.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 203 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: Jan 9, 2018
• Actual Primary Completion Date: Jun 4, 2018
• Actual Study Completion Date: Jul 5, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percent reduction from baseline in serum urate level at the final visit [14 weeks]

   Percent reduction from baseline in serum urate level at the final visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mochida Investigational sites	Tokyo		Japan

Sponsors and Collaborators

• Mochida Pharmaceutical Company, Ltd.
• Fuji Yakuhin Co., Ltd.

Investigators

• Study Director: Kazuki Furuno, Clinical Research Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mochida Pharmaceutical Company, Ltd.
• ClinicalTrials.gov Identifier: NCT03372200
• Other Study ID Numbers: FYU-981-014
• First Posted: Dec 13, 2017
• Last Update Posted: Sep 24, 2018
• Last Verified: Sep 1, 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; Febuxostat; Dotinurad

Study Results

No Results Posted as of Sep 24, 2018