UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038543 |
|---|---|
| Receipt number | 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 | 2024/05/16 11:09:27 |
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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
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
kenizumi@kouhoukai.org
Sponsor or person
Institute
Takagi Hospital
Institute
Department
Personal name
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
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
https://takagi.kouhoukai.or.jp/about/ethics
Publication of results
Unpublished
Result
URL related to results and publications
Unpublishied
Number of participants that the trial has enrolled
80
Results
Currently being reconsidered due to low number of participants
Results date posted
| 2024 | Year | 05 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Currently being reconsidered due to low number of participants
Participant flow
Registration of those who wish to participate
Adverse events
nothing
Outcome measures
Side reactions
Ease of drinking
amount
time
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
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043923
