UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038839 |
|---|---|
| Receipt number | R000044287 |
| Scientific Title | A study of difficulty of swallowing high-volume powdered medicine using auxiliary supplies |
| Date of disclosure of the study information | 2019/12/10 |
| Last modified on | 2019/12/11 13:04:07 |
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Basic information
Public title
A study on the method of taking medicine in healthy people
Acronym
A study on the method of taking medicine in healthy people
Scientific Title
A study of difficulty of swallowing high-volume powdered medicine using auxiliary supplies
Scientific Title:Acronym
A study of difficulty of swallowing high-volume powdered medicine using auxiliary supplies
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the difficulty and time of swallowing different amounts of powder using oblate and medication auxiliary jelly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We study how many powders are usually taken by healthy people.
With respect to taking, we study what is the most favorite in next three methods. 1, powder only, 2, oblate, 3, medication auxiliary jelly.
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
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Lactose (2.5 g, 5 g, 7.5 g, 10 g, and 12.5 g) was ingested in the form of powder 1) only, 2) using oblate, and 3) using medication auxiliary jelly three times in different orders. Points of favorability were selected by participants.
1, most favorable (1 point)
2, secondary favorable (2 points)
3, most dissatisfied (3 points)
2)
(A) You can take them immediately. (1 point)
(B) Taking was more than 10 seconds. (2 points)
(C) Cough or vomiting. So you cannot take smoothly. (3 points)
(D) It was difficult to swallow lactose just by looking at it. (4 points)
Interventions/Control_2
Lactose (2.5 g, 5 g, 7.5 g, 10 g, and 12.5 g) was ingested in the form of powder 1) only, 2) using oblate, and 3) using medication auxiliary jelly three times in different orders. Points of difficulty were selected by participants.
(A) You can take them immediately. (1 point)
(B) Taking was more than 10 seconds. (2 points)
(C) Cough or vomiting. So you cannot take smoothly. (3 points)
(D) It was difficult to swallow lactose just by looking at it. (4 points)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The people who wanted to participate in this study.
Key exclusion criteria
The people who had difficulty swallowing, had difficulty taking powder, were allergic to lactose or agar, had diabetes, or had other serious diseases were excluded.
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, Okawa city, Fukuoka, Japan
TEL
+81-944-87-0001
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, Okawa city, Fukuoka, Japan
TEL
+81-944-87-0001
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
the Ethics Committee of Takagi hospital
Address
Sakemi 141-11, Okawa city, Fukuoka, Japam
Tel
+81-944-87-0001
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
高木病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 10 | 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
22
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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | 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 | 12 | Month | 10 | Day |
Last modified on
| 2019 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044287
