Phase II Exploratory Clinical Study of KUX-1151 | NCT02190786

Studies
Phase II Exploratory Clinical Study of KUX-1151

NCT02190786

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Oct 19, 2015Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Hyperuricemia

Interventions

KUX-1151

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Mar 2015Actual

Completion Date

Not provided

First Submitted Date

Jul 11, 2014

First Submission Date that Met QC Criteria

Jul 13, 2014

First Posted Date

Jul 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2015

Last Update Posted Date

Oct 19, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
KUX-1151, Low dose	Experimental	Drug: KUX-1151
KUX-1151, Middle dose	Experimental	Drug: KUX-1151
KUX-1151, High dose	Experimental	Drug: KUX-1151

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KUX-1151	Drug		KUX-1151, High dose KUX-1151, Low dose KUX-1151, Middle dose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D033461	Hyperuricemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided