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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042559
Receipt No. 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 2020/11/26

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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
Email 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
Email tharada@pharm.showa-u.ac.jp

Sponsor
Institute Showa University
Department of Pharmacology, Clinical Pharmacology, School of Medicine
Institute
Department

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
Email 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 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 Preinitiation
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
2022 Year 01 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
2020 Year 11 Month 26 Day
Last modified on
2020 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048581

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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