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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031503
Receipt No. R000035966
Scientific Title Real clinical practice of gout and hyperuricemia from a cross-sectional study of a Japanese health insurance database
Date of disclosure of the study information 2018/02/27
Last modified on 2019/02/28

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Basic information
Public title Real clinical practice of gout and hyperuricemia from a cross-sectional study of a Japanese health insurance database
Acronym Real clinical practice of gout and hyperuricemia
Scientific Title Real clinical practice of gout and hyperuricemia from a cross-sectional study of a Japanese health insurance database
Scientific Title:Acronym Real clinical practice of gout and hyperuricemia
Region
Japan

Condition
Condition Gout, hyperuricemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the real clinical practice of gout and hyperuricemia using a Japanese health insurance database
Basic objectives2 Others
Basic objectives -Others Real clinical practice
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Prevalence proportion of gout and hyperuricemia
2. Actual situation of prescribing urate-lowering therapy
3. Proportion of patients who achieve the serum uric acid target
4. Frequency of gouty arthritis
5. Real clinical practice of patients with severe renal impairment
Key secondary outcomes

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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) Subjects who continuously identified between April 2016 and March 2017 in a health-care insurance claims database of the Japan Medical Data Center
(2) Patients who identified gout or asymptomatic hyperuricemia
(3) Patients aged between 18 and 65
Key exclusion criteria Patients who identified malignant neoplasms
Target sample size 50000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Horiuchi
Organization Teijin Pharma Limited
Division name Medical Science Department
Zip code
Address 2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL 03-3506-4140
Email tpm-com@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ruriko Koto
Organization Teijin Pharma Limited
Division name Medical Science Department
Zip code
Address 2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL 03-3506-4140
Homepage URL
Email tpm-com@umin.ac.jp

Sponsor
Institute Teijin Pharma Limited
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2018 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
2018 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 01 Month 08 Day

Other
Other related information This is a cross-sectional study using a health-care insurance claims database of the Japan Medical Data Center.

Management information
Registered date
2018 Year 02 Month 27 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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