UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of propranolol on hemangioma and lymphangioma.
Title of the study (Brief title)	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	Miyuki Kohno
Organization	Kanazawa Medical University Hospital
Division name	Department of Pediatric Surgery
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	076-286-2211
Email

Public contact
Name of contact person	Miyuki Kohno
Organization	Kanazawa Medical University Hospital
Division name	Department of Pediatric Surgery
Address
TEL	076-286-2211
Homepage URL
Email	miyuki@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005445