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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033052
Receipt No. R000037683
Official scientific title of the study Safety and pharmacokinetics of meclizine hydrochloride for achondroplasia children
Date of disclosure of the study information 2018/06/20
Last modified on 2018/06/19

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Basic information
Official scientific title of the study Safety and pharmacokinetics of meclizine hydrochloride for achondroplasia children
Title of the study (Brief title) 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 Hiroshi Kitoh
Organization Nagoya University Hospital
Division name Orthopedic Surgery
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550
TEL 052-741-2111
Email hkitoh@med.nagoya-u.ac.jp

Public contact
Name of contact person Masaki Matsushita
Organization Nagoya University Hospital
Division name Orthopedic Surgery
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550
TEL 052-744-2257
Homepage URL
Email masakim@med.nagoya-u.ac.jp

Sponsor
Institute Department of Orthopedic Surgery, Nagoya University Hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 18 Day
Anticipated trial start date
2018 Year 07 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 19 Day
Last modified on
2018 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037683

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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