UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004626 |
|---|---|
| Receipt number | R000005445 |
| Scientific Title | Evaluation of efficacy of propranolol on hemangioma and lymphangioma. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2018/03/15 11:11:13 |
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Basic information
Public title
Evaluation of efficacy of propranolol on hemangioma and lymphangioma.
Acronym
Evaluation of efficacy of propranolol on hemangioma and lymphangioma.
Scientific Title
Evaluation of efficacy of propranolol on hemangioma and lymphangioma.
Scientific Title:Acronym
Evaluation of efficacy of propranolol on hemangioma and lymphangioma.
Region
| Japan |
Condition
Condition
hemangioma, lymphangioma
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
On a hemangioma or mixture of a hemangioma and a lymphangioma or intractable lymphangioma, evaluation of efficacy and safety of propranolol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A change of the lesion size.
Key secondary outcomes
A side effect by blood pressure, the blood sugar level.
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
propranolol therapy
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
| 2 | weeks-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. More than after birth 2 weeks.
2. Hemangioma or lymphangioma.
3. Informed consent.
4. The patient who has contraception.
Key exclusion criteria
1. Severe heart disease.
2. Hypotension.
3. Woman who are pregnant or breast feeding, and woman of childbearing potential.
4. Patient who has drug allergy, and patient with the past of serious side effect by the propranolol drug.
5. Patient who was considered ineligible by the investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyuki Kohno |
Organization
Kanazawa Medical University Hospital
Division name
Department of Pediatric Surgery
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Kohno |
Organization
Kanazawa Medical University Hospital
Division name
Department of Pediatric Surgery
Zip code
Address
TEL
076-286-2211
Homepage URL
miyuki@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University 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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 17 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 26 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005445
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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