UMIN-CTR Clinical Trial

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 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
Email	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
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	IRB
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel	0559895222
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003928