UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037469 |
|---|---|
| Receipt number | R000042715 |
| Scientific Title | Patient Questionnaire Research on Perceived Differences in Usability and Sensation between New and Old Formulations of the Bisono Tape |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2021/01/27 10:51:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Patient Questionnaire Research on Perceived Differences in Usability and Sensation between New and Old Formulations of the Bisono Tape
Acronym
Patient Questionnaire Research on Perceived Differences in Usability and Sensation between New and Old Formulations of the Bisono Tape
Scientific Title
Patient Questionnaire Research on Perceived Differences in Usability and Sensation between New and Old Formulations of the Bisono Tape
Scientific Title:Acronym
Patient Questionnaire Research on Perceived Differences in Usability and Sensation between New and Old Formulations of the Bisono Tape
Region
| Japan |
Condition
Condition
Essential Hypertension
Tachycardiac atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm opinions and impressions regarding usability and sensation of the New and Old formulations of the Bisono Tape with a questionnaire survey in patients who have used both formulations.
Basic objectives2
Others
Basic objectives -Others
Usability and skin sensation
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Usability and skin sensation
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
1) Patients who have been prescribed the Old formulation in the past as well as the new formulation in one and the same pharmacy of Nippon Chouzai Co., Ltd. 2) Patients who receive the medication in person at the pharmacy counter.
Key exclusion criteria
1)Patients with no experience of the Old formulation. 2)Patients who cannot be confirmed to have used it even once following dispensing of the New formulation. 3)Patients who do not visit and receive the medication at a pharmacy of Nippon Chouzai Co., Ltd. (patients under home medication management, hospitalized patients). 4)Patients who have deviated from the specified questionnaire response method. 5)Patients who, in the opinion of the questionnaire interviewer, are not appropriate for the research.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kuniyuki |
| Middle name | |
| Last name | Takeda |
Organization
Japan Medical Research Institute CO.,LTD.
Division name
Sales planning group
Zip code
100-6739
Address
Gran Tokyo North Tower 39F 1-9-1 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-6810-0812
takada-ku@jpmedri.co.jp
Public contact
Name of contact person
| 1st name | Kuniyuki |
| Middle name | |
| Last name | Takeda |
Organization
Japan Medical Research Institute CO.,LTD.
Division name
Sales planning group
Zip code
100-6739
Address
Gran Tokyo North Tower 39F 1-9-1 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-6810-0812
Homepage URL
takada-ku@jpmedri.co.jp
Sponsor or person
Institute
Japan Medical Research Institute CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
TOA EIYO LTD.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Chouzai Co., Ltd, Ethics Committee
Address
Gran Tokyo North Tower 37F 1-9-1 Marunouchi, Chiyoda-ku, Tokyo
Tel
03-6810-0821
fukuoka-k@nicho.co.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
| 2019 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
104
Results
N/A
Results date posted
| 2021 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 30 | Day |
Other
Other related information
1)Questionnaire research(excluding personal information) 2)The Japan Medical Research Institute will make arrangements for requesting Nippon Chouzai Co., Ltd. to select dispensing pharmacy stores and target patients for the questionnaire survey. 3)Following dispensing of a New formulation of the Bisono Tape a pharmacist at the Nippon Chouzai Co., Ltd. pharmacy will explain the purpose and content of the questionnaire survey and, after obtaining consent from the patient, will provide the questionnaire to the patient and receive the answers. 4)The questionnaire responses obtained from Nippon Chouzai Co., Ltd.will be converted to electronic data at the Japan Medical Research Institute after the questionnaire survey has been completed.
Management information
Registered date
| 2019 | Year | 07 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042715
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
