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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014623
Receipt No. R000017014
Scientific Title Study of new drug efficacy index and usefulness of enoxaparin sodium in patients with esophageal cancer
Date of disclosure of the study information 2014/07/23
Last modified on 2018/04/05

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Basic information
Public title Study of new drug efficacy index and usefulness of enoxaparin sodium in patients with esophageal cancer
Acronym Usefulness of Clexane administration of esophageal cancer perioperative
Scientific Title Study of new drug efficacy index and usefulness of enoxaparin sodium in patients with esophageal cancer
Scientific Title:Acronym Usefulness of Clexane administration of esophageal cancer perioperative
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy of enoxaparin sodium venous thromboembolism in (VTE) prevention of post-operative patients with esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of leg vein thrombosis, D-dimer, fibrin monomer complex (FMC), the anti-factor Xa activity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 enoxaparin sodium
Interventions/Control_2 none
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Esophageal cancer patients to be performed abdominal surgery
Key exclusion criteria Patients with a history of hypersensitivity to heparin derivative (1) or heparin
(Bleeding, such as intracranial hemorrhage, retroperitoneal bleeding, in other vital organs) patients who have (2) bleeding
(3) acute endocarditis patients
Renal failure (4) severe (creatinine clearance less than 30mL/min)
Patients with a history (5) heparin-induced thrombocytopenia (HIT)
(6) Other, patients attending physician was deemed inappropriate for participation in this study
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoshihito Tanaka
Organization Gifu University
Division name Surgical Oncology
Zip code
Address 1-1 Yanagido Gifu City
TEL 0582306000
Email yoshihirotana11@hotmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Yoshihito Tanaka
Organization Gifu University
Division name Surgical Oncology
Zip code
Address 1-1 Yanagido Gifu City
TEL 0582306000
Homepage URL
Email yoshihirotana11@hotmail.com

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 23 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
2014 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 23 Day
Last follow-up date
2018 Year 04 Month 04 Day
Date of closure to data entry
2018 Year 04 Month 04 Day
Date trial data considered complete
2018 Year 04 Month 04 Day
Date analysis concluded
2018 Year 04 Month 04 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 23 Day
Last modified on
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017014

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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