UMIN-CTR Clinical Trial

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
Email	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
Email	takada-ku@jpmedri.co.jp

Sponsor
Institute	Japan Medical Research Institute CO.,LTD.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042715