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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020493
Receipt No. 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

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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
Email 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/
Email k-ariyoshi@umin.ac.jp

Sponsor
Institute The University of Tokyo, The Institute of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023589

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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