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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007376
Receipt No. R000008686
Scientific Title Efficacy and safety of novel NK-1 antagonist, Fosaprepitant for the prevention of CINV
Date of disclosure of the study information 2012/03/01
Last modified on 2015/02/13

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Basic information
Public title Efficacy and safety of novel NK-1 antagonist, Fosaprepitant for the prevention of CINV
Acronym Efficacy and safety of Fosaprepitant for the prevention of CINV
Scientific Title Efficacy and safety of novel NK-1 antagonist, Fosaprepitant for the prevention of CINV
Scientific Title:Acronym Efficacy and safety of Fosaprepitant for the prevention of CINV
Region
Japan

Condition
Condition Patients receiving highly or moderately emetogenic agents
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of fosaprepitant in patients receiving highly or moderately emetogenic agents
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)CTCAE ver.4.0
2)MAT
Key secondary outcomes 1)Questionnaire of convenience
2)Toxicity and side effect

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1)Adult
2)Patients receiving highly or moderately emetogenic agents 3)A consent form for participating in this study is submitted
Key exclusion criteria 1)Patients having past history of hypersensitivity to fosaprepitant
2)Used Pimozide
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Tsuji
Organization Kobe City Medical Center General Hospital
Division name Department of Medical oncology
Zip code
Address 2-1-1,Minatojima-Minamimachi,Chuo-ku, Kobe city,Japan
TEL 078-302-4321
Email tsuji@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Tsuji
Organization Kobe City Medical Center General Hospital
Division name Department of Medical oncology
Zip code
Address 2-1-1,Minatojima-Minamimachi,Chuo-ku, Kobe city,Japan
TEL 078-302-4321
Homepage URL
Email tsuji@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 神戸市立医療センター中央市民病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2012 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
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate the efficacy and safety and convenience and Toxicity and side effect of fosaprepitant in patients receiving highly or moderately emetogenic agents

Management information
Registered date
2012 Year 02 Month 24 Day
Last modified on
2015 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008686

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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