UMIN-CTR Clinical Trial

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
Email	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
Email	takuya96matsuda@yahoo.co.jp

Sponsor
Institute	Dept. of Pediatr., Oosaka Medical Univ. Sch. of Med.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038680