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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011944
Receipt No. R000013929
Scientific Title Propranolol for infantile hemangiomas
Date of disclosure of the study information 2013/10/03
Last modified on 2019/09/14

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Basic information
Public title Propranolol for infantile hemangiomas
Acronym Propranolol for infantile hemangiomas
Scientific Title Propranolol for infantile hemangiomas
Scientific Title:Acronym Propranolol for infantile hemangiomas
Region
Japan

Condition
Condition Infantile hemangiomas
Classification by specialty
Pediatrics Plastic surgery Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify a safety and efficiency of propranolol medication for infantile hemangiomas
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Volume of hemangioma(measured by MRI, CT and photograph)
Key secondary outcomes Side effect

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients will start propranolol medication at the dose of 1mg/kg per day.
After 1-2 weeks the dose of propranolol will increase at 2mg/kg/per day.
The patients will follow at the outpatient clinic every month.
Unless the patients produce harmful effects, the medication will be taken for 6 months.
Interventions/Control_2
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
3 months-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have the disability due to hemangiomas
Key exclusion criteria Patients who have the contraindication of propranolol
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kishi
Organization Keio university, School of Medicine
Division name Plastic and Reconstructive Surgery
Zip code
Address 35 shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email kkishi@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Aramaki
Organization Keio university, School of medicine
Division name Plastic and Reconstructive Surgery
Zip code
Address 35 shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email nonken@2001.jukuin.keio.ac.jp

Sponsor
Institute Plastic and Reconstructive Surgery,
Keio university, School of medicine
Institute
Department

Funding Source
Organization Plastic and Reconstructive Surgery,
Keio university, School of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 10 Month 03 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
2013 Year 09 Month 01 Day
Date of IRB
2013 Year 06 Month 03 Day
Anticipated trial start date
2013 Year 10 Month 15 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 02 Day
Last modified on
2019 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013929

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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