Phase II Exploratory Clinical Study of KUX-1151

NCT ID: NCT02190786

Last Updated: 2015-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Hyperuricemia

Study Groups

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KUX-1151, Low dose

Group Type EXPERIMENTAL

KUX-1151

Intervention Type DRUG

KUX-1151, Middle dose

Group Type EXPERIMENTAL

KUX-1151

Intervention Type DRUG

KUX-1151, High dose

Group Type EXPERIMENTAL

KUX-1151

Intervention Type DRUG

Interventions

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KUX-1151

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo and Other Japanese City, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KUX1201

Identifier Type: -

Identifier Source: org_study_id

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