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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038543
Receipt No. R000043923
Scientific Title A Study of Method of Administering Powdered Medicines in healthy people
Date of disclosure of the study information 2019/11/30
Last modified on 2019/12/10

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Basic information
Public title A Study of Method of Administering Powdered Medicines
Acronym A Study of Method of Administering Powdered Medicines
Scientific Title A Study of Method of Administering Powdered Medicines in healthy people
Scientific Title:Acronym A Study of Method of Administering Powdered Medicines in healthy people
Region
Japan

Condition
Condition healthy participants
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the difficulty of swallowing different amounts of lactose powder using oblate and medication auxiliary jelly.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In general people, three methods (only powder per oral, oblate use and medication auxiliary jelly use) actually taking lactose in, to examine the degree of difficulty in taking and the time it took to take.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 In different order and method, various amount of lactose was ingested.
Initially, participants swallowed (1) powder only, (2) oblate use and (3) medication auxiliary jelly use in order.
Interventions/Control_2 The second time, (1) oblate use (2) medication auxiliary jelly use (3) only powder were carried out in order.
Interventions/Control_3 Finally, (1) medication auxiliary jelly (2) powder only (3) oblate use were done in order.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria healthy adults who want to participate in the study are registered.
Key exclusion criteria The people who have disabilities swallowing, who have difficulty taking powder, who are allergic to lactose or agar, people with diabetes, or who have other serious diseases are excepted.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name kenichi
Middle name
Last name izumi
Organization Takagi Hospital
Division name Preventive medicine and Internal Medicine
Zip code 831-0016
Address Sakemi 141-11, Ookawa city, Fukuoka
TEL 0944870001
Email kenizumi@kouhoukai.org

Public contact
Name of contact person
1st name kenichi
Middle name
Last name izumi
Organization Takagi Hospital
Division name Preventive medicine and Internal Medicine
Zip code 831-0016
Address Sakemi 141-11, Ookawa city, Fukuoka, Japan
TEL 0944870001
Homepage URL
Email kenizumi@kouhoukai.org

Sponsor
Institute Takagi Hospital
Institute
Department

Funding Source
Organization Takagi Hospital
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 Takagi Hospital IRB
Address Sakemi 141-11, Ookawa city, Fukuoka, Japan
Tel 0944870001
Email rinri-shinsa@kouhoukai.org

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 11 Month 30 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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 30 Day
Date of IRB
2018 Year 10 Month 01 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 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
2019 Year 11 Month 11 Day
Last modified on
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043923

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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