UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033052 |
|---|---|
| Receipt number | R000037683 |
| Scientific Title | Safety and pharmacokinetics of meclizine hydrochloride for achondroplasia children |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2018/12/19 12:58:13 |
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Basic information
Public title
Safety and pharmacokinetics of meclizine hydrochloride for achondroplasia children
Acronym
Safety and pharmacokinetics of meclizine
Scientific Title
Safety and pharmacokinetics of meclizine hydrochloride for achondroplasia children
Scientific Title:Acronym
Safety and pharmacokinetics of meclizine
Region
| Japan |
Condition
Condition
achondroplasia
Classification by specialty
| Pediatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of safety as well as 24-hour pharmacokinetics and accumulation at 1 week after single dose of meclizine.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24-hour pharmacokinetics of meclizine
drug accumulation
adverse events and side effects
Key secondary outcomes
Simulation of pharmacokinetics in repeated administration of meclizine for 14 days
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
single dose
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
| 5 | years-old | <= |
Age-upper limit
| 11 | years-old | > |
Gender
Male and Female
Key inclusion criteria
achondroplasia children
Key exclusion criteria
body weight of less than 11 kg
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitoh |
Organization
Nagoya University Hospital
Division name
Orthopedic Surgery
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550
TEL
052-741-2111
hkitoh@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Matsushita |
Organization
Nagoya University Hospital
Division name
Orthopedic Surgery
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550
TEL
052-744-2257
Homepage URL
masakim@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
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
Address
Tel
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
| 2018 | Year | 06 | Month | 20 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 21 | 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 | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037683
