UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study to evaluate acceptabilities of minitablets in children
Acronym	Clinical study to evaluate acceptabilities of minitablets in children
Scientific Title	Clinical study to evaluate acceptabilities of minitablets in children
Scientific Title:Acronym	Clinical study to evaluate acceptabilities of minitablets in children
Region	Japan

Condition
Condition	Children undergoing internal treatment
Classification by specialty	Child
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	Safety
Basic objectives -Others
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	Medicine 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	2 years-old <=
Age-upper limit	8 years-old >=
Gender	Male and Female
Key inclusion criteria	1) The patients have a chronic disease,and need taking medicine routinely. 2) Age between 2 - 8 years old at the time of informed consent. 3) The patient without swallowing disorder. 4) The patients who can be obtained informed consent by their guardians.
Key exclusion criteria	1) Any drug allergy. 2) Subjects who are inadequate for enrollment judged by the investigators
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Noriko Middle name Last name Noriko
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
1st 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	1758577
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	Department of Pediatrics, Showa University School of Medicine
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	昭和大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 26 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	65
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	2018 Year 11 Month 22 Day
Date of IRB	2018 Year 11 Month 29 Day
Anticipated trial start date	2019 Year 01 Month 04 Day
Last follow-up date	2019 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	2018 Year 11 Month 26 Day
Last modified on	2019 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039917