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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042922
Receipt No. R000048979
Scientific Title Influence investigation by the pharmacist follow after the medication
Date of disclosure of the study information 2021/01/06
Last modified on 2021/01/06

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Basic information
Public title Influence investigation by the pharmacist follow after the medication
Acronym Influence investigation by the pharmacist follow after the medication
Scientific Title Influence investigation by the pharmacist follow after the medication
Scientific Title:Acronym Influence investigation by the pharmacist follow after the medication
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Medicine in general Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Whether the follow of the pharmacist after the medication is effective and examines the effectiveness of the method
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes medication adherence
Key secondary outcomes The number of side effects
Change of the HbA1c level
Patient evaluation of the pharmacist follow

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Follow with the telephone of the pharmacist
Interventions/Control_2 Follow with the letter of the pharmacist
Interventions/Control_3 No follow of the pharmacist
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 The patient whom antidiabetic agent was prescribed for more than 28 days
Key exclusion criteria The patient who receives visit drug management instruction
The patient who cannot list the VAS method by a physical reason
The patient who does not have legal representative
Target sample size 385

Research contact person
Name of lead principal investigator
1st name Shutaro
Middle name
Last name Yokota
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 043-247-1352
Email drug-info@c-yaku.or.jp

Public contact
Name of contact person
1st name Shutaro
Middle name
Last name Yokota
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 043-247-1352
Homepage URL
Email drug-info@c-yaku.or.jp

Sponsor
Institute others
Chiba Pharmaceutical Association
Institute
Department

Funding Source
Organization others
Chiba Pharmaceutical Association
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 043-247-1352
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
2021 Year 01 Month 06 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
2020 Year 10 Month 27 Day
Date of IRB
2020 Year 10 Month 27 Day
Anticipated trial start date
2021 Year 01 Month 25 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 06 Day
Last modified on
2021 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048979

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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