UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029988 |
|---|---|
| Receipt number | R000032934 |
| Scientific Title | Effect and safety on carteorol for infantile hemangioma |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2017/11/15 18:19:24 |
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Basic information
Public title
Effect and safety on carteorol for infantile hemangioma
Acronym
Effect and safety on carteorol for infantile hemangioma
Scientific Title
Effect and safety on carteorol for infantile hemangioma
Scientific Title:Acronym
Effect and safety on carteorol 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 clarify the effect and safety on carteorol for infantile hemangioma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Availability of carteorol therpy after 24weeks administration
Key secondary outcomes
Hemangioma size, color and shape after 24weeks administration
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 administartion of carteorol
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
| 35 | days-old | <= |
Age-upper limit
| 150 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Proliferating infantile hemangioma
over 1.5cm
2 informed consent
Key exclusion criteria
1 congenital hemangioma, Kasabah-Merritt
syndrome
2 hypoglycemia, hypotension, bradycardia
(arrhythmia), cardiac function disorder
3 Otehr drug administaraion interacted
with carteorol within 14 days
4 history of other therapy foy infantile
hemangioma(steroid therapy, laser therapy etc)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamichi Uchiyama |
Organization
Takatsuki General Hospital
Division name
Department of Pediatrics
Zip code
Address
1-3-13 Kosobecho, Takatsuki city, Osaka, Japan
TEL
072-681-3801
uchiyama@ajk.takatsuki-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamichi Uchiyama |
Organization
Takatsuki General Hospital
Division name
Department of Pediatrics
Zip code
Address
1-3-13 Kosobecho, Takatsuki city, Osaka, Japan
TEL
072-681-3801
Homepage URL
uchiyama@ajk.takatsuki-hp.or.jp
Sponsor or person
Institute
Takatsuki General Hospital
Institute
Department
Personal name
Funding Source
Organization
Takatsuki General Hospital
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
医療法人愛仁会高槻病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 15 | Day |
Last modified on
| 2017 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032934
