UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008498 |
|---|---|
| Receipt number | R000009308 |
| Scientific Title | Propranolol for a treatment of lymphatic malformation |
| Date of disclosure of the study information | 2012/07/24 |
| Last modified on | 2015/05/29 15:35:53 |
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Basic information
Public title
Propranolol for a treatment of lymphatic malformation
Acronym
Propranolol study for lymphatic malformation
Scientific Title
Propranolol for a treatment of lymphatic malformation
Scientific Title:Acronym
Propranolol study for lymphatic malformation
Region
| Japan |
Condition
Condition
lymphatic malformation
Classification by specialty
| Vascular surgery | Pediatrics | Dermatology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To asess the effect and safety of propranolol treatment for lymphatic malformation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
bleeding and pain
Key secondary outcomes
(Reduction ratio)
Measured by MRI and echo images of lymphatic malformation
(Other)
Changes in the lymphoid follicles (Safety endpoints)
Bradycardia, hypotension, drowsiness, insomnia, rash, diarrhea, difficulty breathing, wheezing, decreased blood glucose
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
| 0 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)They are diagnosed as a lymphatic malformation.
2)They have symptoms of bleeding or pain. 3)They have no indication of surgical treatment and sclerotherapy.
Key exclusion criteria
1) Heart disease
2) Hypotension (Systolic blood pressure < 70mmHg)
3) Bradycardia (Pulse rate <60/min)
4) Asthma
5) Diabetic ketoacidosis,metabolic acidosis
6)idiopathic hypoglycemia,uncontroled diabetes (Blood suger < 60mg/dl)
7)fasted state over one month
8)peripheral circulatory disturbance
9)untreated phenochromocytoma
10)administration of thioridazine
11)administration of rizatriptan benzoate
12)oral use of antihypertensive agent
13)oral use or local injection of adrenal cortical steroid
14)Patient who was considered ineligible by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsunaga Narushima |
Organization
University of Tokyo
Division name
plastic and reconstructive surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
sancho123jp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsunaga Narushima |
Organization
University of Tokyo
Division name
plastic and reconstructive surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
sancho123jp@yahoo.co.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
Department of plastic and reconstructive surgery
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 24 | 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
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2015 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009308
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
