UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007376 |
|---|---|
| Receipt number | 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 21:05:16 |
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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
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
tsuji@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008686
