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Phase II Exploratory Clinical Study of KUX-1151

Primary Purpose

Hyperuricemia

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

KUX-1151

About this trial

This is an interventional trial for Hyperuricemia focused on measuring Hyperuricemia

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

KUX-1151, Low dose

KUX-1151, Middle dose

KUX-1151, High dose

Arm Description

Outcomes

Primary Outcome Measures

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

Percent change from baseline in serum uric acid level

Change from baseline in serum uric acid level

Secondary Outcome Measures

Full Information

NCT ID

NCT02190786

First Posted

July 11, 2014

Last Updated

October 16, 2015

Sponsor

Kissei Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02190786

Brief Title

Phase II Exploratory Clinical Study of KUX-1151

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

March 2015 (Actual)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kissei Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia

Keywords

Hyperuricemia

7. Study Design

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Arm Title

KUX-1151, Low dose

Arm Type

Experimental

Arm Title

KUX-1151, Middle dose

Arm Type

Experimental

Arm Title

KUX-1151, High dose

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

KUX-1151

Primary Outcome Measure Information:

Title

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

Time Frame

14 weeks

Title

Percent change from baseline in serum uric acid level

Time Frame

14 weeks

Title

Change from baseline in serum uric acid level

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Tokyo and Other Japanese City

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Phase II Exploratory Clinical Study of KUX-1151

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