UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035360 |
|---|---|
| Receipt number | R000040294 |
| Scientific Title | A nationwide survey of olanzapine for antiemetic therapy |
| Date of disclosure of the study information | 2018/12/26 |
| Last modified on | 2023/01/13 18:09:00 |
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Basic information
Public title
A nationwide survey of olanzapine for antiemetic therapy
Acronym
A nationwide survey of olanzapine for antiemetic therapy
Scientific Title
A nationwide survey of olanzapine for antiemetic therapy
Scientific Title:Acronym
A nationwide survey of olanzapine for antiemetic therapy
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A nationwide survey on the use of olanzapine for antiemetic therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A frequency of discontinuation of olanzapine.
Key secondary outcomes
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
The patients who received high/moderate emetic risk chemotherapy and given olanzapine.
Key exclusion criteria
The patients who undergoing another clinical trial.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Toshinobu |
| Middle name | |
| Last name | Hayashi |
Organization
Fukuoka University Hospital
Division name
Department of pharmacy
Zip code
8140180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL
0928716631
toshinobu@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshinobu |
| Middle name | |
| Last name | Hayashi |
Organization
Fukuoka University
Division name
Department of pharmacy
Zip code
814-0180
Address
Nanakuma
TEL
+81928716631
Homepage URL
toshinobu@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Hospital
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka
Tel
0928716631
toshinobu@fukuoka-u.ac.jp
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
| 2018 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
http://jascc.jp/info/
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
| Delay expected |
Results Delay Reason
Delays in data collection and analysis
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
Main results already published
Date of protocol fixation
| 2018 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Design
Observational study
This retrospective observational study was conducted from June 2018 to September 2018.
Patients
Male and female patients (aged over 20 years) who underwent HEC or MEC, and given olanzapine.
Survey
1.Patient's background
2.Prophylaxis or rescue
3.Use of olanzapine
4.Use of olanzapine for elderly
5.Concomitant use of hypnotic agents
6.Use of olanzapine for the cancer patient with DM
7.The frequency of use of olanzapine
8.Cause of discontinuation of olanzapine
9.Antiemetic effect of olanzapine
Management information
Registered date
| 2018 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040294
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
