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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001065
Receipt No. R000001292
Scientific Title Evaluation of the steroid ointment utility to prevent the injection site reactions and phlebitis caused by vinorelbine.
Date of disclosure of the study information 2012/12/31
Last modified on 2009/05/07

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Basic information
Public title Evaluation of the steroid ointment utility to prevent the injection site reactions and phlebitis caused by vinorelbine.
Acronym Prevention of the vinorelbine phlebitis.
Scientific Title Evaluation of the steroid ointment utility to prevent the injection site reactions and phlebitis caused by vinorelbine.
Scientific Title:Acronym Prevention of the vinorelbine phlebitis.
Region
Japan

Condition
Condition cancer
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the steroid ointment utility to prevent the injection site reactions and phlebitis caused by vinorelbine.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes phlebitis
Key secondary outcomes

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
Interventions/Control_1 steroid ointment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cancer patient treated by Navelbine
Good organ functions
More than 2months survival
Key exclusion criteria Hypersensivity to steroid ointment.
Treating with steroid.
Having no adequate vessel to observe phlebitis.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Nakamura
Organization Nagasaki University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagasaki University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL
Homepage URL
Email

Sponsor
Institute Nagasaki Thoracic Oncology Group
Institute
Department

Funding Source
Organization no
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
2012 Year 12 Month 31 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 Terminated
Date of protocol fixation
2007 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 05 Month 01 Day
Date analysis concluded
2009 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 03 Month 04 Day
Last modified on
2009 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001292

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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