UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020493 |
|---|---|
| Receipt number | R000023589 |
| Scientific Title | Japan PHarmacological Audit study of Safety and Efficacy in Real world (Phase-R) Nausea and Vomiting Study |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2019/04/03 09:06:14 |
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Basic information
Public title
Japan PHarmacological Audit study of Safety and Efficacy in Real world (Phase-R) Nausea and Vomiting Study
Acronym
Phase-R Nausea and Vomiting Study
Scientific Title
Japan PHarmacological Audit study of Safety and Efficacy in Real world (Phase-R) Nausea and Vomiting Study
Scientific Title:Acronym
Phase-R Nausea and Vomiting Study
Region
| Japan |
Condition
Condition
malignancy
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of olanzapine for nausea and vomiting in patients with cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
average nausea NRS on day 2
Key secondary outcomes
adverse events
symptom relief scale
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with cancer being cared for by hospital palliative care teams aged 18 years or older who receive olanzapine treatment for nausea and vomiting
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isseki Maeda |
Organization
Osaka University Hospital
Division name
Oncology Center
Zip code
Address
2-15 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-5111
maeda@pm.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Ariyoshi |
Organization
The University of Tokyo, The Institute of Medical Science
Division name
Department of Palliative Medicine
Zip code
Address
4-6-1 Shiroganedai, Minato-ku, Tokyo, Japan
TEL
03-3443-8111
Homepage URL
http://www.jortc.jp/
k-ariyoshi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo, The Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
独立行政法人 国立がん研究センター東病院（千葉県）
小牧市民病院（岐阜県）
神戸大学大学院（兵庫県）
大阪大学医学部附属病院（大阪府）
聖隷浜松病院（静岡県）
東京大学医学部附属病院（東京都）
東京大学医科学研究所附属病院（東京都）
九州がんセンター（福岡県）
国立病院機構 近畿中央胸部疾患センター（大阪府）
独立行政法人 国立がん研究センター中央病院（東京都）
筑波大学附属病院（茨城県）
帝京大学附属病院（東京都）
名古屋市立大学病院（愛知県）
聖路加国際病院（東京都）
横浜労災病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 12 | 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
| 2014 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study design: cohort study
patient recruitment: eligible patients who are cared for by a participating hospital palliative care team from January, 2016
measurements: average nausea NRS, number of vomiting episode, symptom relief scale, primary disease, previous treatments, concomitant treatments
Management information
Registered date
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2019 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023589
| 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 |
