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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name