UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006623 |
|---|---|
| Receipt number | R000007592 |
| Scientific Title | Assessment of the therapeutic effect of oral propranolol on retinochoroidal hemangioma |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2013/12/08 01:01:41 |
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Basic information
Public title
Assessment of the therapeutic effect of oral propranolol on retinochoroidal hemangioma
Acronym
Oral propranolol therapy for retinochoroidal hemangioma
Scientific Title
Assessment of the therapeutic effect of oral propranolol on retinochoroidal hemangioma
Scientific Title:Acronym
Oral propranolol therapy for retinochoroidal hemangioma
Region
| Japan |
Condition
Condition
retinochoroidal hemangioma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of oral propranolol therapy for retinochoroidal hemangioma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity, size of retinochoroidal hemangioma
Key secondary outcomes
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 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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with visual impairment due to retinochoroidal hemangioma
Key exclusion criteria
patients ineligible for oral propranolol therapy or considered ineligible for this clinical trial by investigators
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Tanabe |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Ophthalmology
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001. Japan
TEL
052-951-1111
tennsyoudragon@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Tanabe |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Ophthalmology
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001. Japan
TEL
052-951-1111
Homepage URL
tennsyoudragon@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2011 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 28 | Day |
Last modified on
| 2013 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007592
