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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Orthostatic Dysregulation | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saijo central hospital | ||||||
Division name | Pediatrics | ||||||
Zip code | 793-0027 | ||||||
Address | 804, Tsuitachi, Saijo, Ehime | ||||||
TEL | 0897560300 | ||||||
break_down@hotmail.co.jp |
Public contact | |||||||
Name of contact person |
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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/ | ||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |