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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009368
Receipt No. R000011009
Scientific Title Efficacy of omegacin for fibrile neutropenia
Date of disclosure of the study information 2012/11/20
Last modified on 2012/11/20

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Basic information
Public title Efficacy of omegacin for fibrile neutropenia
Acronym fibrile neutropenia and omegacin
Scientific Title Efficacy of omegacin for fibrile neutropenia
Scientific Title:Acronym fibrile neutropenia and omegacin
Region
Japan

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

Objectives
Narrative objectives1 establishnment of an adequate empiric therapy for fiblrile neutropenia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes efficacy
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 omegacin
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 fibrile neutropenia
Key exclusion criteria serious abnormality of heart, liver and renal function
allergy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shosaku Nomura
Organization Kansai Medical University
Division name First Department of Internal Medicine
Zip code
Address 10-15, Fumizono-cho, Moriguchi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kansai Medical University
Division name First Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email nomurash@hirakata.kmu.ac.jp

Sponsor
Institute First Department of Internal Medicine, Kansai Medical University
Institute
Department

Funding Source
Organization First Department of Internal Medicine, Kansai Medical University
Organization
Division
Category of Funding Organization Other
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 11 Month 20 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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 20 Day
Last modified on
2012 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011009

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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