- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190786
Phase II Exploratory Clinical Study of KUX-1151
October 16, 2015 updated by: Kissei Pharmaceutical Co., Ltd.
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo and Other Japanese City, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: KUX-1151, Low dose
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Experimental: KUX-1151, Middle dose
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Experimental: KUX-1151, High dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL
Time Frame: 14 weeks
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14 weeks
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Percent change from baseline in serum uric acid level
Time Frame: 14 weeks
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14 weeks
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Change from baseline in serum uric acid level
Time Frame: 14 weeks
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14 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
July 11, 2014
First Submitted That Met QC Criteria
July 13, 2014
First Posted (Estimate)
July 15, 2014
Study Record Updates
Last Update Posted (Estimate)
October 19, 2015
Last Update Submitted That Met QC Criteria
October 16, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUX1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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