UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040829 |
|---|---|
| Receipt number | R000046609 |
| Scientific Title | Questionnaire survey on participation in treatment for general consumers |
| Date of disclosure of the study information | 2020/06/19 |
| Last modified on | 2021/04/12 10:23:40 |
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Basic information
Public title
Questionnaire survey on participation in treatment for general consumers
Acronym
Questionnaire survey on participation in treatment
Scientific Title
Questionnaire survey on participation in treatment for general consumers
Scientific Title:Acronym
Questionnaire survey on participation in treatment
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The intention to participate in the selection of therapeutic agents and the intention to continue eye drops and the intention to continue to visit a hospital by participating in the selection of therapeutic agents will be investigated in general consumers who have not been diagnosed with glaucoma, assuming that they have been diagnosed with glaucoma for the first time.
Basic objectives2
Others
Basic objectives -Others
Intention to participate in the selection of therapeutic agens
Intention to adhere to instillation and continue visiting hospitals by participating in the selection of therapeutic agents
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intention to participate in the selection of therapeutic agents
Intention to adhere to instillation and continue visiting hospitals by participating in the selection of therapeutic agents
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
General consumers over the age of 40 who have never been diagnosed with glaucoma
Key exclusion criteria
Those who previously diagnosed with glaucoma
Those who have relatives diagnosed with glaucoma
Medical professionals (doctors, pharmacists, nurses, etc.)
Those engaged in the manufacturing of pharmaceuticals and medical products
Person engaged in drug marketing
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Hori |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9603
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Etsuyo |
| Middle name | |
| Last name | Miyamoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9603
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1, 3, Kichijoji Kita-cho, Musashino-shi, Tokyo
Tel
070-5011-8550
shingo-namiki@cmicgroup.com
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
| 2020 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
108
Results
More than 70 percent of the subjects answered that they would like to be involved in drug selection when they are diagnosed with glaucoma for the first time and decide on a treatment, and they indicated higher treatment compliance and intention to continue hospital visits when they involved in drug selection. From these facts, it is considered desirable for patients to be involved in the drug selection in in order to improving adherence.
Results date posted
| 2021 | Year | 04 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 27 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire survey in the venue
Subjects were recruited from a research panel living in Kansai area.
Management information
Registered date
| 2020 | Year | 06 | Month | 19 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046609
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
