UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023795 |
|---|---|
| Receipt number | R000026929 |
| Scientific Title | English |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2017/03/01 23:09:13 |
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Basic information
Public title
English
Acronym
English
Scientific Title
English
Scientific Title:Acronym
English
Region
| Japan |
Condition
Condition
swallowing function
Classification by specialty
| Oto-rhino-laryngology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
English
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hearing
Key secondary outcomes
EMG
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A group: schedule of swallowing capsules
1. Water
2. Capsule with water
3. Magic jelly
4. Capsule with magic jelly
Interventions/Control_2
B group: schedule of swallowing capsules
1. Magic jelly
2. Capsule with magic jelly
3. Water
4. Capsule with water
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
English
Key exclusion criteria
English
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maki Yoneko |
Organization
Medical and Health Resources Research Institute
Division name
Director
Zip code
Address
4-38-7, Higashi-Ikebukuro, Toshiba-ku, Tokyo 170-0013, Japan
TEL
03-5904-8534
research@mhrri.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Yoneko |
Organization
Medical and Health Resources Research Institute
Division name
Research section
Zip code
Address
4-38-7, Higashi-Ikebukuro, Toshiba-ku, Tokyo 170-0013, Japan
TEL
03-5904-8534
Homepage URL
research@mhrri.com
Sponsor or person
Institute
Medical and Health Resources Research Institute
Institute
Department
Personal name
Funding Source
Organization
Ryukakusan Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京都立産業技術研究センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026929
