UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004292 |
|---|---|
| Receipt number | R000005121 |
| Scientific Title | Breakthrough for Overcoming Lymph Edema |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2015/01/16 08:42:59 |
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Basic information
Public title
Breakthrough for Overcoming Lymph Edema
Acronym
BTOLE
Scientific Title
Breakthrough for Overcoming Lymph Edema
Scientific Title:Acronym
BTOLE
Region
| Japan |
Condition
Condition
Lymph edema
Classification by specialty
| Cardiology | Dermatology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Overcoming lymph edema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grade of edema (circumference and subcutaneous area of deseased limb on CT)
Key secondary outcomes
Pain (VAS), Grade of lymph congestion (lymph scintigraphy), Skin perfusion pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cilostazol
6 months
200 mg/2x
Interventions/Control_2
aspirin
6 months
100 mg/1x
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese adult with lymph edema
Key exclusion criteria
1, cancer carriers
2, patients with remarkable hemorrhage
3, patients with tachycardia or severe ischemic heart disease
4, patients who already took aspirin or cilostazol
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Fukuda |
Organization
National Center for Global Health and Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo 162-8655
TEL
03-3202-7181
sfukuda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Tanuma |
Organization
National Center for Global Health and Medicine
Division name
Medical Research Management Office
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo 162-8655
TEL
03-3202-7181
Homepage URL
shinzou.gimu@hosp.ncgm.go.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | 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 | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 09 | Month | 29 | Day |
Last modified on
| 2015 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005121
