UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037716
Receipt No. 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 (Ver. 4)

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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
Email 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
Email minami@aono-pharm.co.jp

Sponsor
Institute Drug Information Center, Chiba Pharmaceutical Association
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043016