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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000036029 |
Receipt No. | 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 |
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 |
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Condition | ||||||
Condition | Gout and Hyperuricemia | |||||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Key exclusion criteria | Patients who have malignancy.
(This criteria is not applied for denominator when calculating diagnosis and treatment rates for gout/hyperuricemia.) |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
h.horiuchi@teijin.co.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
Other related information | This is a cross-sectional study of health insurance database provided by JMDC Inc. in Japan. |
Management information | |||||||
Registered date |
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Last modified on |
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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 | |
Registered date | File name |
Research case data | |
Registered date | File name |