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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000038839
Receipt No. 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

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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
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, Okawa city, Fukuoka, Japan
TEL +81-944-87-0001
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 the Ethics Committee of Takagi hospital
Address Sakemi 141-11, Okawa city, Fukuoka, Japam
Tel +81-944-87-0001
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044287

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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