UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017859 |
|---|---|
| Receipt number | R000020694 |
| Scientific Title | Study to establish a new masticatory test for dysphagia |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2015/06/10 14:24:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study to establish a new masticatory test for dysphagia
Acronym
Study to establish a new masticatory test for dysphagia
Scientific Title
Study to establish a new masticatory test for dysphagia
Scientific Title:Acronym
Study to establish a new masticatory test for dysphagia
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among patients with dysphagia taking food substances which doesn't require mastication, we investigate how many patients who can eat rice crackers there are and want to make a test to evaluate the masticatory function of dysphagia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
aspiration, penetration, oral residue, pharyngeal residue, function of bolus preparation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
When patients with dysphagia eat rice crackers, we investigate whether or not they can eat them as safely as they eat meals not required mastication.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a patient with dysphagia who takes meal which doesn't require mastication
Key exclusion criteria
a patient who cannot take meal through his or her mouth
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruka Tohara |
Organization
Tokyo medical and dental university
Division name
Tokyo medical and dental university hospital faculty of dentistry, Gerodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL
03-5803-4560
haruka-t@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itoe Tagashira |
Organization
Tokyo medical and dental university
Division name
Tokyo medical and dental university hospital faculty of dentistry, Gerodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL
03-5803-5562
Homepage URL
i.tagashira.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university hospital faculty of dentistry,Gerodontology
Institute
Department
Personal name
Funding Source
Organization
None
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
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
東京医科歯科大学歯学部附属病院（Tokyo medical and dental university hospital faculty of dentistry）（東京都）、新八千代病院（Shinyachiyo hospital）（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | 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
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2015 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020694
