UMIN-CTR Clinical Trial

Basic information
Public title	Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Acronym	Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Scientific Title	Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Scientific Title:Acronym	Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Region	Japan

Condition
Condition	Orthostatic Dysregulation
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of Hangebyakujutenmato for orthostatic dysregulation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement rate of subjective symptom visual analogue scale (VAS) score
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A receives Hangebyakujutenmato in the I stage and midodrine hydrochloride in the II stage. Phase I and Phase II are 4 weeks each. There will be a 2-4 week washout period between Phase I and Phase II.
Interventions/Control_2	Group B receives midodrine hydrochloride in stage I and Hangebyakujutenmato in stage II. Phase I and Phase II are 4 weeks each. There will be a 2-4 week washout period between Phase I and Phase II.
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	7 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	When all of the following are satisfied 1) Persons who have obtained written consent for participation in the research 2) 7 years old or older and under 18 years old at the time of obtaining consent 3) Those who have been diagnosed with orthostatic dysregulation by a doctor and whose symptoms are not improved by non-drug therapy
Key exclusion criteria	When one or more of the following are satisfied 1) Those who cannot discontinue other treatments that may affect the symptoms of orthostatic dysregulation 2) Those who suffering from acute diseases such as upper respiratory tract inflammation and acute gastroenteritis 3) Those who cannot exclude underlying diseases other than orthostatic dysregulation 4) Those who have difficulty communicating 5) Others who the principal investigator deems inappropriate as a subject
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Nishimura
Organization	Saijo central hospital
Division name	Pediatrics
Zip code	793-0027
Address	804, Tsuitachi, Saijo, Ehime
TEL	0897560300
Email	break_down@hotmail.co.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Nishimura
Organization	Saijo central hospital
Division name	Pediatrics
Zip code	793-0027
Address	804, Tsuitachi, Saijo, Ehime
TEL	0897560300
Homepage URL	http://www.saijo-c-hospital.jp/
Email	break_down@hotmail.co.jp

Sponsor
Institute	Saijo central hospital
Institute
Department

Funding Source
Organization	none
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	Saijo central hospital
Address	804, Tsuitachi, Saijo, Ehime
Tel	0897560300
Email	break_down@hotmail.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	西条中央病院

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 01 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	2020 Year 06 Month 16 Day
Date of IRB	2020 Year 06 Month 26 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2023 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 17 Day
Last modified on	2020 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048495

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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