UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050845 |
|---|---|
| Receipt number | R000057824 |
| Scientific Title | Elucidation of Texture Elements Contributing to the Ease of Ingestion of Orally Disintegrating Tablets (OD Tablets) |
| Date of disclosure of the study information | 2023/04/14 |
| Last modified on | 2023/04/14 13:29:12 |
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Basic information
Public title
Elucidation of Texture Elements Contributing to the Ease of Ingestion of Orally Disintegrating Tablets (OD Tablets)
Acronym
Elucidation of Texture Elements Contributing to the Ease of Ingestion of OD Tablets
Scientific Title
Elucidation of Texture Elements Contributing to the Ease of Ingestion of Orally Disintegrating Tablets (OD Tablets)
Scientific Title:Acronym
Elucidation of Texture Elements Contributing to the Ease of Ingestion of OD Tablets
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to develop formulations that are easier to swallow and are universally applicable, it is necessary to establish an evaluation method for OD tablets with high quantitative and reproducible performance using equipment analysis. Therefore, we would like to measure the differences in particle size, quantity, and compaction pressure of OD tablets (crystalline cellulose), compare them to sensory tests, and use them as indicators for objective evaluation of ease of swallowing. This would enable us to create various OD tablets with different degrees of ease of swallowing and also objectively evaluate the ease of swallowing of existing formulations, leading to improved compliance with medication.
Basic objectives2
Others
Basic objectives -Others
In order to develop formulations that are easier to swallow and are universally applicable, it is necessary to establish an evaluation method for OD tablets with high quantitative and reproducible performance using equipment analysis. Therefore, we would like to measure the differences in particle size, quantity, and compaction pressure of OD tablets (crystalline cellulose), compare them to sensory tests, and use them as indicators for objective evaluation of ease of swallowing. This would enable us to create various OD tablets with different degrees of ease of swallowing and also objectively evaluate the ease of swallowing of existing formulations, leading to improved compliance with medication.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. the texture of the tablets on a 7-point scale using the Semantic Differential(SD) method
2. free comment
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The age range for obtaining consent is between 20 and 69 years old.
2. Individuals who are healthy without any diseases that require regular visits to the hospital and who do not have any restrictions on sugar intake.
Key exclusion criteria
1. Individuals with a history of food allergies to any of the following: shrimp, crab, abalone, squid, salmon roe, salmon, mackerel, egg, wheat, buckwheat, peanuts, milk, soybeans, walnuts, almonds, cashew nuts, sesame seeds, peaches, bananas, apples, oranges, kiwi fruit, chicken, pork, beef, yams, matsutake mushrooms, or gelatin.
2. Individuals with a history of drug allergies.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Koyanagi |
Organization
Taste & Aroma Strategic Research Institute
Division name
Research & Development Department
Zip code
104-0033
Address
1 Chome-17-24 Shinkawa, Chuo City, Tokyo
TEL
03-5542-3850
m-koyanagi@e-mikaku.com
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Nakamitsu |
Organization
Taste & Aroma Strategic Research Institute
Division name
Corporate Planning Department
Zip code
104-0033
Address
1 Chome-17-24 Shinkawa, Chuo City, Tokyo
TEL
03-5542-3850
Homepage URL
n-nakamitsu@e-mikaku.com
Sponsor or person
Institute
Taste & Aroma Strategic Research Institute
Institute
Department
Personal name
Funding Source
Organization
SAWAI PHARMACEUTICAL 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
Medical and Health Resources Research Institute
Address
4-Chome-38-7, Tokyo, Higashiikebukuro, Toshima City, Tokyo
Tel
(03)-5904-8534
kojima@mhrri.com
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
| 2023 | Year | 04 | Month | 14 | 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
58
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
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057824
