UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036029
Receipt number R000041038
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
Date of disclosure of the study information 2019/02/27
Last modified on 2019/02/27 16:33:41

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


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 or person

Institute

Teijin Pharma Limited

Institute

Department

Personal name



Funding Source

Organization

Teijin Pharma Limited

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



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

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041038


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name