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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008498
Receipt No. 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

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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
Email 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
Email sancho123jp@yahoo.co.jp

Sponsor
Institute University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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