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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042486
Receipt No. R000048495
Scientific Title Study for the effectiveness of drug therapy for orthostatic dysregulation in children
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/17

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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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