Phase II Exploratory Clinical Study of KUX-1151

Hyperuricemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190786
• Other study ID #: KUX1201
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2014
• Last updated: October 16, 2015

Study information

• Verified date: October 2015
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• KUX-1151

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving serum uric acid level = 6 mg/dL		14 weeks	No
Primary	Percent change from baseline in serum uric acid level		14 weeks	No
Primary	Change from baseline in serum uric acid level		14 weeks	No