UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028908 |
|---|---|
| Receipt number | 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 | 2020/06/10 14:12:41 |
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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 | Masayo |
| Middle name | |
| Last name | Komoda |
Organization
Tokyo University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
278-8510
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL
04-7121-4134
komo1207@rs.noda.tus.ac.jp
Public contact
Name of contact person
| 1st name | Masayo |
| Middle name | |
| Last name | Komoda |
Organization
Tokyo University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
278-8510
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL
04-7121-4134
Homepage URL
komo1207@rs.noda.tus.ac.jp
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
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
Tokyo University of Science
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
Tel
0471214134
komo1207@rs.noda.tus.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
| 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033070
| 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 |
