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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035360
Receipt No. R000040294
Scientific Title A nationwide survey of olanzapine for antiemetic therapy
Date of disclosure of the study information 2018/12/26
Last modified on 2019/06/26

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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
Email 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
Email toshinobu@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

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
Email 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
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
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
Date trial data considered complete
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
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040294

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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