UMIN-CTR Clinical Trial

Basic information
Public title	A cross-sectional study of health insurance database in Japan: Real-world surveillance for treatment of pediatric gout/ hyperuricemia with urate lowering agents
Acronym	Real-world surveillance for treatment of pediatric gout/asymptomatic hyperuricemia with urate lowering agents
Scientific Title	A cross-sectional study of health insurance database in Japan: Real-world surveillance for treatment of pediatric gout/ hyperuricemia with urate lowering agents
Scientific Title:Acronym	Real-world surveillance for treatment of pediatric gout/asymptomatic hyperuricemia with urate lowering agents
Region	Japan

Condition
Condition	Gout and Hyperuricemia
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism Nephrology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the real clinical practice for treatment of pediatric gout/hyperuricemia with urate lowering agents using a health insurance database in Japan
Basic objectives2	Others
Basic objectives -Others	Diagnosis and treatment status
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Prevalence rate and treatment rate with urate lowering agents for pediatric gout/asymptomatic hyperuricemia patients. 2. Patients' characteristics: patients with diagnosis and/or urate lowering treatment (ULT) in pediatric gout/asymptomatic hyperuricemia. 3. Number of ULT prescribed patients, average dosage, adherence and change of ULT agents 4. Incidence and prevalence of gouty arthritis
Key secondary outcomes	Not Applicable

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects who are continuously identified in a JMDC Claim Database during the period between April 2016 and March 2017. If necessary, subjects who are identified between April 2012 and March 2016 would be analyzed as well. 2. Patients who have gout or asymptomatic hyperuricemia. (This criteria is not applied for denominator when calculating diagnosis and treatment rates for gout/hyperuricemia.) 3. Patients ages between 0 and 18 years old.
Key exclusion criteria	Patients who have malignancy. (This criteria is not applied for denominator when calculating diagnosis and treatment rates for gout/hyperuricemia.)
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideki Horiuchi, PhD.
Organization	Teijin Pharma Limited
Division name	Medical Science Department
Zip code
Address	2-1, Kasumigaseki 3-Chome, Chiyoda-ku, Tokyo 100-8585, Japan
TEL	+81-3-3506-4140
Email	h.horiuchi@teijin.co.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoko Torii, MSc.
Organization	Teijin Pharma Limited
Division name	Medical Science Department
Zip code
Address	2-1, Kasumigaseki 3-Chome, Chiyoda-ku, Tokyo 100-8585, Japan
TEL	+81-3-3506-4140
Homepage URL
Email	tpm-com@umin.ac.jp

Sponsor
Institute	Teijin Pharma Limited
Institute
Department

Funding Source
Organization	Teijin Pharma Limited
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date	2019 Year 01 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a cross-sectional study of health insurance database provided by JMDC Inc. in Japan.

Management information
Registered date	2019 Year 02 Month 27 Day
Last modified on	2019 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041038

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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