UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042486
Receipt number 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 2023/11/20 10:33:00

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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

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement rate of subjective symptom visual analogue scale (VAS) score

Key secondary outcomes

Incidence of Adverse Events, Blood Pressure and Pulse in New Orthostatic Test


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 or person

Institute

Saijo central hospital

Institute

Department

Personal name



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

Open public recruiting

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

2025 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

2023 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048495


Research Plan
Registered date File name
2023/05/22 ★★OD研究計画書★★.docx

Research case data specifications
Registered date File name
2023/05/22 ⑤OD-CRF(症例報告書).docx

Research case data
Registered date File name