UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031503 |
|---|---|
| Receipt number | 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 | 2020/03/30 17:47:58 |
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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
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
tpm-com@umin.ac.jp
Sponsor or person
Institute
Teijin Pharma Limited
Institute
Department
Personal name
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
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
Partially published
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 08 | Day |
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
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035966
