UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037469
Receipt No. 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 2019/07/24

* 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
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
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
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
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.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


Contact us.