UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042559 |
|---|---|
| Receipt number | R000048581 |
| Scientific Title | A study to evaluate the acceptability of mini-tablets in infants from 6 months of age and under 2 years of age |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2022/06/12 22:18:07 |
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Basic information
Public title
A study to evaluate the acceptability of mini-tablets in infants from 6 months of age and under 2 years of age
Acronym
A study to evaluate the acceptability of mini-tablets in infants from 6 months of age and under 2 years of age
Scientific Title
A study to evaluate the acceptability of mini-tablets in infants from 6 months of age and under 2 years of age
Scientific Title:Acronym
A study to evaluate the acceptability of mini-tablets in infants from 6 months of age and under 2 years of age
Region
| Japan |
Condition
Condition
Children in need of oral treatment
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate acceptabilities of minitablet(placebo, diameter 2mm) for children.
Basic objectives2
Others
Basic objectives -Others
The amount of water needed when taking the drug
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ability of swallowing the medicine
Key secondary outcomes
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
ingestion of Minitablet
Interventions/Control_2
ingestion of Syrup
Interventions/Control_3
ingestion of Granule
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
| 6 | months-old | <= |
Age-upper limit
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic illnesses who are hospitalized in or out of Showa University Hospital and require daily medication
2) Patients who are more than 6 months and less than 2 years old at the time of obtaining informed consent.
3) Patients who have started weaning and have no problems with swallowing function
4) Patients who have received written consent from their representatives to participate in this study
Key exclusion criteria
1) Patients who have been allergic to drugs
2) Patients deemed ineligible to participate in the study by their physician-in-charge
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Hida |
Organization
Showa University
Division name
Department of Pharmacology, Clinical Pharmacology, School of Medicine
Zip code
157-8577
Address
6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo
TEL
03-3300-5254
n.hida@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Harada |
Organization
Showa University
Division name
Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy
Zip code
1428555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8203
Homepage URL
tharada@pharm.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Department of Pharmacology, Clinical Pharmacology, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa Univ. IRB
Address
1-5-8, Hatanodai, Shinagawaw-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.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
| 2020 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35057092/
Number of participants that the trial has enrolled
40
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
| 2020 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 26 | Day |
Last modified on
| 2022 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048581
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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