UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003246 |
|---|---|
| Receipt number | R000003928 |
| Scientific Title | Safety and efficacy of Enoxaparine sodium after oncogynecological surgical patients:phase 2 study |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2019/09/01 14:31:22 |
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Basic information
Public title
Safety and efficacy of Enoxaparine sodium after oncogynecological surgical patients:phase 2 study
Acronym
Safety and efficacy of Enoxaparine sodium after oncogynecological surgical patients:phase 2 study
Scientific Title
Safety and efficacy of Enoxaparine sodium after oncogynecological surgical patients:phase 2 study
Scientific Title:Acronym
Safety and efficacy of Enoxaparine sodium after oncogynecological surgical patients:phase 2 study
Region
| Japan |
Condition
Condition
gynecological cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
confirmation of safety of enoxaparin sodium after oncogynecological surgical patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
incidence of bleeding event
Key secondary outcomes
incidence of venous thromboembolism
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
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
low weight molecular heparin 2times per day 7-14 days
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
oncogynecological surgical patients
Key exclusion criteria
bleeder etc
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobutaka |
| Middle name | |
| Last name | Takahashi |
Organization
shizuoka cancer center
Division name
gynecology
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
n.takahashi@scchr.jp
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Takahashi |
Organization
shizuoka cancer center
Division name
gynecology
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
n.takahashi@scchr.jp
Sponsor or person
Institute
Kansai clinical oncology group
Institute
Department
Personal name
Funding Source
Organization
Kansai clinical oncology group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel
0559895222
irb@scchr.jp
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
大阪医科大学（大阪府）、関西労災病院（兵庫県）、京都府立医科大学（京都府）、静岡がんセンター（静岡県）、聖隷浜松病院（静岡県）、名古屋市立大学（愛知県）、奈良医科大学（奈良県）、奈良県立奈良病院（奈良県）、兵庫医科大学（兵庫県）、三重大学（三重県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | 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 | 02 | Month | 04 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 23 | Day |
Last modified on
| 2019 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003928
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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