Phase II Exploratory Clinical Study of KUX-1151

Phase 2

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: KUX-1151

• Registration Number: NCT02190786
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-13
• Study First Posted: 2014-07-15
• Primary Completion: 2015-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Japanese HU patients (Outpatient)
• Patients who meet the following criteria concerning serum uric acid levels at the screening [1) Gout: > 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without complications: ≥ 9.0 mg/dL]

Exclusion Criteria

• Patients who have any symptom of gouty arthritis within 2 weeks of investigational product administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KUX-1151, Middle dose	KUX-1151	-
KUX-1151, Low dose	KUX-1151	-
KUX-1151, High dose	KUX-1151	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in serum uric acid level	14 weeks
Change from baseline in serum uric acid level	14 weeks
Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL	14 weeks