UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033945 |
|---|---|
| Receipt number | R000038680 |
| Scientific Title | Examination of the usefulness of the musculoskeltal ultrasonography on hyperuricemia in children |
| Date of disclosure of the study information | 2018/08/30 |
| Last modified on | 2021/09/07 14:32:59 |
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Basic information
Public title
Examination of the usefulness of the musculoskeltal ultrasonography on hyperuricemia in children
Acronym
Examination of the usefulness of the musculoskeltal ultrasonography on hyperuricemia in children
Scientific Title
Examination of the usefulness of the musculoskeltal ultrasonography on hyperuricemia in children
Scientific Title:Acronym
Examination of the usefulness of the musculoskeltal ultrasonography on hyperuricemia in children
Region
| Japan |
Condition
Condition
Hyperuricemia in children
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the usefulness of the musculoskeletal ultrasonography
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An uric acid sodium salt (MUS) crystal is composed and aims at the structure obstacle such as inflammatory views and the consequent quality of bone and skin change and soft tissue obstacle for the evaluation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Musculoskeletal ultrasonography
Interventions/Control_2
one time
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
| 5 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hyperuricemia in children
Key exclusion criteria
The affected child whom the affected child with the lesion except an injury and the gout, a mental condition judged to supersonic wave enforcement joint if the study person in charge including the patient that an affected child thought to be the intolerance, a family or the person refused inspection for inspection or a study cooperator was inappropriate as a subject.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TAKUYA |
| Middle name | |
| Last name | MATSUDA |
Organization
Oosaka Medical Univ. Sch. of Med.
Division name
Pediatric
Zip code
569-8686
Address
2-7 Daigaku, Takatsuki-shi, Oosaka
TEL
072-683-1221
takuya96matsuda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | TAKUYA |
| Middle name | |
| Last name | MATSUDA |
Organization
Oosaka Medical Univ. Sch. of Med.
Division name
Pediatric
Zip code
569-8686
Address
2-7 Daigaku, Takatsuki-shi, Oosaka
TEL
072-683-1221
Homepage URL
takuya96matsuda@yahoo.co.jp
Sponsor or person
Institute
Dept. of Pediatr., Oosaka Medical Univ. Sch. of Med.
Institute
Department
Personal name
Funding Source
Organization
Dept. of Pediatr., Oosaka Medical Univ. Sch. of Med.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dept. of Pediatr., Oosaka Medical Univ. Sch. of Med.
Address
2-7 Daigaku, Takatsuki-shi, Oosaka
Tel
072-683-1221
takuya96matsuda@yahoo.co.jp
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 | 08 | Month | 30 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038680
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
