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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003246
Receipt No. 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 2017/03/03

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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
Obsterics 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
Middle name
Last name Nobutaka Takahashi
Organization shizuoka cancer center
Division name gynecology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Email n.takahashi@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobutaka Takahashi
Organization shizuoka cancer center
Division name gynecology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Homepage URL
Email n.takahashi@scchr.jp

Sponsor
Institute Kansai clinical oncology group
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2010 Year 02 Month 04 Day
Date of IRB
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
2017 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003928

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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