UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011695 |
|---|---|
| Receipt number | R000013675 |
| Scientific Title | An open study for effectiveness of tipepidine hibenzate in ADHD children |
| Date of disclosure of the study information | 2013/09/10 |
| Last modified on | 2019/03/31 23:27:04 |
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Basic information
Public title
An open study for effectiveness of tipepidine hibenzate in ADHD children
Acronym
Asverin study for ADHD children
Scientific Title
An open study for effectiveness of tipepidine hibenzate in ADHD children
Scientific Title:Acronym
Asverin study for ADHD children
Region
| Japan |
Condition
Condition
Attention deficit hyperactivity disorder (ADHD)
Classification by specialty
| Psychosomatic Internal Medicine | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and Efficacy of tipepidine hibenzate in children with ADHD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADHD-RS
Clincal global impression
DN-CAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral tipepidine hibenzate intake
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
| 6 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Have a clinical diagnosis of ADHD confirmed according to DSM4 criteria.
2) Currently attending Fukui University hospital as an outpatient.
3) Must not be on medication, otherwise no oral intake of medication except for the following; methylphenidate, atomoxetine, atypical antipschotic medication( risperidone, olanzapine, aripiprazole, blonanserin, paliperidone).
4) Subjects within the age range of 6 to 17 years old.
5) No changes in medication for at least 4 weeks prior to baseline visit.
6) Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Key exclusion criteria
1) Hypersensitivity towards tipepidine hibenzate.
2) Subjects who have not yet received informed consent of the current diagnosis.
3) Subjects who have any other current DSM4 diagnosis of the following;
"Pervasive development disorder", "Schizophrenia and Other Psychotic Disorders","Delirium, Dementia, and Amnestic and Other Cognitive Disorders", "Substance-Related Disorders(exemption of Caffeine related and nicotine related disorders)","mood disorders","eating disorders","personality disorders".
4) Subjects who have a physical disorder with a need of strict diet, or a diagnosis of a severe physical disorder.
5) Subjects who are receiving medication other than the above mentioned.
6) Women who are breastfeeding, pregnant, possibility of pregnancy, or have a wish of early pregnancy.
7) Subjects who have participated in other clinical studies 3 months prior to this study.
8) Subjects who are planned for an immediate therapeutic plan change due to unstable physical or psychological symptoms.
9) Subjects who have a history of suicide attempt within the past 1 year.
10) Subjects who, in the Investigator's opinion, might not be suitable for the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Tomoda |
Organization
University of Fukui, Research Center for Child Mental Development
Division name
Division of Psychosocial Support for Nurturing
Zip code
910-1193
Address
Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN 910-1193
TEL
0776-61-8677
atomoda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Tomoda |
Organization
University of Fukui, Research Center for Child Mental Development
Division name
Division of Psychosocial Support for Nurturing
Zip code
910-1193
Address
Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN, 910-1193
TEL
0776-61-8677
Homepage URL
atomoda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui, Research Center for Child Mental Development, Division of Psychosocial Support for Nurturing
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, University of Fukui
Address
Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN, 910-1193
Tel
0776-61-8529
chiken@ml.u-fukui.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
| 2013 | Year | 09 | Month | 10 | 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
16
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
| 2013 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013675
| Research Plan | |
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| Registered date | File name |
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