UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005624 |
|---|---|
| Receipt number | R000006609 |
| Scientific Title | Efficacy and safety of Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with hematological malignancies after highly emetogenic chemotherapy |
| Date of disclosure of the study information | 2011/05/22 |
| Last modified on | 2011/11/29 17:17:32 |
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Basic information
Public title
Efficacy and safety of Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with hematological malignancies after highly emetogenic chemotherapy
Acronym
Efficacy and safety of Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with hematological malignancies after highly emetogenic chemotherapy
Scientific Title
Efficacy and safety of Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with hematological malignancies after highly emetogenic chemotherapy
Scientific Title:Acronym
Efficacy and safety of Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with hematological malignancies after highly emetogenic chemotherapy
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the effect and safety of Aprepitant for prevention of Chemotherapy-induced nausea and vomiting in patients with hematological malignancies after highly emetogenic chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with no emesis and no nausea in overall phase (0-120 hours after chemotherapy)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Aprepitant on days 1 to 3
Granisetron on day 1
Dexamethasone on days 1 to 4
Interventions/Control_2
Granisetron on day 1
Dexamethasone on days 1 to 4
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient can take Aprepitant for internal use.
Key exclusion criteria
1.Hypersensitivity for Aprepitant.
2.Patient is receiving treatment with pimozide.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Fujii |
Organization
Tokushima University Hospital
Division name
Division of Hematology
Zip code
Address
2-50-1 Kuramoto-cho,Tokushima,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima University Hospital
Division name
Division of Hematology
Zip code
Address
TEL
088-633-7120
Homepage URL
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 05 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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
| 2011 | Year | 05 | Month | 21 | Day |
Last modified on
| 2011 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006609
