UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037716 |
|---|---|
| Receipt number | R000043016 |
| Scientific Title | Promotion of generic drugs using questionnaire |
| Date of disclosure of the study information | 2019/08/21 |
| Last modified on | 2020/08/17 10:25:55 |
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Basic information
Public title
Promotion of generic drugs using questionnaire
Acronym
POGDUQ
Scientific Title
Promotion of generic drugs using questionnaire
Scientific Title:Acronym
POGDUQ
Region
| Japan |
Condition
Condition
First patient contact
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Gain publicity of the generic drugs
Basic objectives2
Others
Basic objectives -Others
Promotion of generic drugs
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of select generic drugs
Key secondary outcomes
Percentage of knowledge
Percentage of non-selected generic drugs
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Questionnaire (5~10 minutes)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First patient contact of selected brand drugs
Key exclusion criteria
Patient selects generic drugs
Patient visited when the investigator was absent
Those have difficulty dealing in Japanese
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, chuo-ku, Chiba-shi, Chiba 260-0025, Japan
TEL
043-247-4402
minami@aono-pharm.co.jp
Public contact
Name of contact person
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Aono Minamigyotoku Yakkyoku
Division name
Aono Minamigyotoku Yakkyoku
Zip code
272-0143
Address
4-15-2, Ainokawa, Ichikawa-shi, Chiba, 272-0143, Japan
TEL
047-356-4193
Homepage URL
minami@aono-pharm.co.jp
Sponsor or person
Institute
Drug Information Center, Chiba Pharmaceutical Association
Institute
Department
Personal name
Funding Source
Organization
Drug Information Center, Chiba Pharmaceutical Association
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aono Minamigyotoku Yakkyoku
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Pharmaceutical Association
Address
9-2 Tonyacho, chuo-ku, Chiba-shi, Chiba 260-0025, Japan
Tel
043-247-4401
drug-info@c-yaku.or.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 | 08 | Month | 21 | 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
28
Results
No significant differences were observed in the primary endpoint (x2 goodness-of-fit test) and the secondary endpoint (x2 independence test).
Results date posted
| 2020 | Year | 03 | Month | 02 | Day |
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
| 2019 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043016
