Phase II Exploratory Clinical Study of KUX-1151

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.

Completed

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Key information

Conditions

Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo and Other Japanese City, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KUX-1151

Drug

Primary outcomes

Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL

Time frame: 14 weeks
Percent change from baseline in serum uric acid level

Time frame: 14 weeks
Change from baseline in serum uric acid level

Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Primary completion: 2015
First posted: Jul 15, 2014
Registry last updated: Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed