UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011944 |
|---|---|
| Receipt number | R000013929 |
| Scientific Title | Propranolol for infantile hemangiomas |
| Date of disclosure of the study information | 2013/10/03 |
| Last modified on | 2019/09/14 21:38:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
nonken@2001.jukuin.keio.ac.jp
Sponsor or person
Institute
Plastic and Reconstructive Surgery,
Keio university, School of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013929
