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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012123
Receipt No. R000014177
Scientific Title Clinical study to elucidate the efficacy of oral propranolol treatment for infantile hemangiomas
Date of disclosure of the study information 2013/10/25
Last modified on 2018/04/30

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Basic information
Public title Clinical study to elucidate the efficacy of oral propranolol treatment for infantile hemangiomas
Acronym Oral propranolol treatment for infantile hemangiomas
Scientific Title Clinical study to elucidate the efficacy of oral propranolol treatment for infantile hemangiomas
Scientific Title:Acronym Oral propranolol treatment for infantile hemangiomas
Region
Japan

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

Objectives
Narrative objectives1 Assessing the efficasy and safety of oral propranolol treatment for infantile hemangiomas
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in color and size of infantile hemangiomas, and side effects of propranolol treatment
Key secondary outcomes

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 Oral propranolol
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
1 months-old <=
Age-upper limit
12 months-old >=
Gender Male and Female
Key inclusion criteria 1.Proliferating infantile hemangiomas
2.Informed consent
Key exclusion criteria 1.Patient who has a severe complication without infantile hemangiomas
2.Patient with the past of serious side effect by the propranolol drug
3.Patient with cardiac disease, asthma or carbohydrate metabolism
4.Patient who was considered ineligible by the investigators
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayato Hayashi
Organization Juntendo University School of Medicine
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email ayhayasi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayato Hayashi
Organization Juntendo University School of Medicine
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email ayhayasi@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Juntendo 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 25 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 10 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 25 Day
Last follow-up date
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 25 Day
Last modified on
2018 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014177

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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