UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035006 |
|---|---|
| Receipt number | R000039917 |
| Scientific Title | Clinical study to evaluate acceptabilities of minitablets in children |
| Date of disclosure of the study information | 2018/11/26 |
| Last modified on | 2019/05/27 15:08:20 |
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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
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
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
1758577
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039917
