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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028908
Receipt No. R000033070
Scientific Title Development studies of electronic patient's diary to improve pharmacist's CINV countermeasure (pre-trial)
Date of disclosure of the study information 2017/08/30
Last modified on 2017/08/30

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Basic information
Public title Development studies of electronic patient's diary to improve pharmacist's CINV countermeasure (pre-trial)
Acronym Development studies of electronic patient's diary to improve pharmacist's CINV countermeasure (pre-trial)
Scientific Title Development studies of electronic patient's diary to improve pharmacist's CINV countermeasure (pre-trial)
Scientific Title:Acronym Development studies of electronic patient's diary to improve pharmacist's CINV countermeasure (pre-trial)
Region
Japan

Condition
Condition CINV chemotherapy induced nausea and vomiting
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To make clear the feeling of use of electronic patient's diary and CINV pharmaceutical management system to make it useful for system improvement
Basic objectives2 Others
Basic objectives -Others Use feeling of electronic patient diary
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of electronic patient's diary
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Have the CINV symptom input for 7 days by using electronic patient's diary
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 1.patients undergoing hospitalization or outpatient chemotherapy
2.Patient who is 20 years old or more and can enter smartphone or personal computer
3.Patient who signed, based on his/her free will, to the clinical trial agreement with full understanding of the purpose of this conducted trial and its insights
Key exclusion criteria 1.Patients who may cause substrate or functional nausea / vomiting such as gastrointestinal transit disorder, brain metastasis, electrolyte abnormality, uremia, etc.
2.patients using emetic drugs in combination
3.patients taking antipsychotics with antiemetic actions, antiemetics and steroids on a regular basis
4.pregnant
5.judged by the investigator to be inappropriate for this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayo Komoda
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL 04-7121-4134
Email komo1207@rs.noda.tus.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayo Komoda
Organization Tokyo University of Science
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL 04-7121-4134
Homepage URL
Email komo1207@rs.noda.tus.ac.jp

Sponsor
Institute Tokyo University of Science
Institute
Department

Funding Source
Organization Tokyo University of Science
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 30 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 10 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
2017 Year 08 Month 30 Day
Last modified on
2017 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033070

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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