UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057324 |
|---|---|
| Receipt number | R000048074 |
| Scientific Title | Clinical application of medication supporting jelly 'Paste-ststate oblate' evaluated by the PILL-5 |
| Date of disclosure of the study information | 2025/03/20 |
| Last modified on | 2025/03/18 16:50:54 |
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Basic information
Public title
Clinical application of medication supporting jelly 'Paste-ststate oblate' evaluated by the PILL-5
Acronym
Clinical application of medication supporting jelly evaluated by the PILL-5
Scientific Title
Clinical application of medication supporting jelly 'Paste-ststate oblate' evaluated by the PILL-5
Scientific Title:Acronym
Clinical application of medication supporting jelly evaluated by the PILL-5
Region
| Japan |
Condition
Condition
Patients who are admitted in convalescent period rehabilitation unit
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the applicability of 'Paste-state oblate', one of the medication supporting jellys using the pill dysphagia evaluating tool 'PILL-5'
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PILL-5
Key secondary outcomes
Evaluation of easiness and taste of the 'Paste-state oblate'
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Experimental group: When taking a medicine, use the 'Paste state oblate' for a week
Interventions/Control_2
Control group: Taking a medicine as usual
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
1. Gave written informed consent by patient
2. 20 years or older
3. Take a medicine from oral
4. Have enough language ability and cognitive function to perform the sensory evaluation of easiness and taste
Key exclusion criteria
1. Unstable condition
2. Take the medicine which are unstable under acid condition
3. Unable to perform sensory evaluation due to language and cognitive dysfunction
4. Judged as inappropriate for the study by the principle investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
otaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Inamoto |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-9000
Homepage URL
inamoto@fujita-hu.ac.jp
Sponsor or person
Institute
Faculty of Rehabilitation, School of Health Sciences, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitation Medicine I, School of Medicine, Fujita Health Unversity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
NUTRI
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel
0562-93-2167
inamoto@fujita-hu.ac.jp
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
| 2025 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.jsdr.or.jp/wp-content/uploads/file/meeting/annual_meeting_no28_abstracts.pdf#page=198
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jsdr.or.jp/wp-content/uploads/file/meeting/annual_meeting_no28_abstracts.pdf#page=198
Number of participants that the trial has enrolled
24
Results
The median (range) of PILL-5 scores in the intervention group/control group was 2 (range 0-10)/3 (0-6) at baseline, 0 (range 0-8)/2 (0-6) on the first day, and 0 (range 0-6)/2 (0-6) on the last day. Regarding changes from baseline, the difference in scores on the first day was significantly larger in the intervention group (p=0.037) (Figure 3). However, there was no significant difference in the changes from baseline to the last day between groups.
Results date posted
| 2025 | Year | 03 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no significant differences in age, type of disease, MMSE, FIM cognition, the number of pills taken and PILL-5 score at baseline between intervention group and control group.
Participant flow
Out of 126 individuals from whom consent was obtained, PILL-5 was conducted on 125 individuals. Among them, 43 individuals scoring less than 6 on PILL-5 (from October 9, 2020, to March 31, 2021) and 58 individuals scoring less than 1 on PILL-5 (from April 1, 2021, to December 27, 2021) were excluded, leaving 24 participants for random allocation. Twelve participants each were assigned to the intervention group and the control group. One participant from the intervention group was transferred to acute care ward due to deterioration and dropped out before the intervention.
Adverse events
There was no adverse effects.
Outcome measures
Primary outcome: PILL-5 score at Baseline, Day 1 and Day 7
Secondary outcome: Subjective evaluation of the taste and ease of swallowing of the jelly paste, as well as a safety assessment for only intervention group
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 10 | 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
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048074
