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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004292 |
Receipt No. | R000005121 |
Scientific Title | Breakthrough for Overcoming Lymph Edema |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2015/01/16 |
Basic information | ||
Public title | Breakthrough for Overcoming Lymph Edema | |
Acronym | BTOLE | |
Scientific Title | Breakthrough for Overcoming Lymph Edema | |
Scientific Title:Acronym | BTOLE | |
Region |
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Condition | ||||
Condition | Lymph edema | |||
Classification by specialty |
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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 |
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Interventions/Control_1 | cilostazol
6 months 200 mg/2x |
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Interventions/Control_2 | aspirin
6 months 100 mg/1x |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Cardiovascular Surgery, National Center for Global Health and Medicine |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005121 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |