UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020220 |
|---|---|
| Receipt number | R000023353 |
| Scientific Title | Efficacy of proplanorol for infantile hemangioma |
| Date of disclosure of the study information | 2016/01/15 |
| Last modified on | 2017/06/17 20:24:05 |
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Basic information
Public title
Efficacy of proplanorol for infantile hemangioma
Acronym
Proplanorol for infantile hemangioma
Scientific Title
Efficacy of proplanorol for infantile hemangioma
Scientific Title:Acronym
Proplanorol for infantile hemangioma
Region
| Japan |
Condition
Condition
Infantile Hemangioma
Classification by specialty
| Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy proplanorol to infantile hemangiomas with the risk of life-threatening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate at 12 weeks
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral administration of proplanorol
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
| 0 | years-old | <= |
Age-upper limit
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)patients with Infantile Hemangioma
in Tohoku University Hospital Department of Pediatrics
(2)Infant with huge Hemangioma that on the face and neck, near the eyelid
(3)Patients without any organ failure
(4) Written consent is necessary.
Key exclusion criteria
Patients with ..
cardiogenic shock
sinus bradycardia
long QT syndrome
hypotension
atrioventricular block
heart failure
bronchial asthma
infectious diseases
hypersensitivity to propranolol
Kasabach-Merritt syndrome
PHACE syndrome
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Sasahara |
Organization
Tohoku University Hospital
Division name
Department of Pediatrics
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7287
ysasahara@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Rikiishi |
Organization
Tohoku University Hospital
Division name
Department of Pediatrics
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7287
Homepage URL
trikiishi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
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
| 2016 | Year | 01 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 15 | 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
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023353
