臨床研究等提出・公開システム

Japanese

Date of registration	April. 03, 2023
Last modified on	Dec. 23, 2024
Trial ID	jRCT2041230001

Scientific Title	An exploratory clinical trial to Investigate the efficacy and safety of Meclizine hydrochloride in Achondroplasia patients (pediatrics). (MACH trial)
Public Title	An exploratory clinical trial to Investigate the efficacy and safety of Meclizine hydrochloride in Achondroplasia patients (pediatrics). (MACH trial)

Contact for Scientific Queries	Name	Matsushita Masaki
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
	Telephone	+81-52-744-2111
	E-mail	matsushita.masaki.a7@f.mail.nagoya-u.ac.jp
Contact for Public Queries	Name	Kato Yuichi
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
	Telephone	+81-52-744-2942
	E-mail	kato.yuichi.y8@f.mail.nagoya-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 03, 2023
Actual date of first enrollment		May. 15, 2023
Target sample size		9
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who have been confirmed to Definite or Probable among the achondroplasia diagnostic criteria created by the Intractable Diseases Research Group of the Ministry of Health, Labor and Welfare more than one year before obtaining consent. 2) Patients whose age at the time of obtaining consent is 5 to 11 years old. 3)Patients with documented height data between 12 and 3 months prior to enrollment
	Exclusion Criteria	1) Patients who started treatment with a growth hormone preparation within 1.5 years (78 weeks) before obtaining informed consent 2) Patients who have been treated with drugs (CNP analogues, statins, etc.) for which basic or clinical data have been reported to suppress FGFR3 signals within 1 year before obtaining informed consent 3) Patients who have taken medicines such as motion sickness medicines containing meclizine hydrochloride continuously for more than 2 weeks within 1 year before obtaining informed consent, expecting bone lengthening effects. 4) Patients who have undergone bone lengthening surgery within 1 year or patients who are planning to perform bone lengthening surgery during the study drug administration period 5)Pregnant, lactating, or potentially pregnant female patients, or both male and female patients who cannot agree to use contraception during the study period under the guidance of the princepal investigator or subinvestigator.
	Age Minimum	5age old over
	Age Maximum	11age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Achondroplasia
Intervention(s)		Administered MECLIZIN oraly once a daily for 26 weeks.
Health Condition(s) Keyword		FGFR3, Short stature
Intervention(s) Keyword
Health Condition(s) Code		D000130
Intervention(s) Code
Primary Outcome(s)		Safety: Safety data for 7 months from the first treatment Efficacy: Growth rate
Secondary Outcome(s)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagoya University Hospital Institutional Review Board (IRB)
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Aichi
Telephone	+81-52-744-1958
E-Mail	center-irb@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 28, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
8	Dec. 23, 2024	(this page)	Changes
7	July. 22, 2024	Detail	Changes
6	Jan. 22, 2024	Detail	Changes
5	July. 20, 2023	Detail	Changes
4	June. 25, 2023	Detail	Changes
3	June. 07, 2023	Detail	Changes
2	May. 17, 2023	Detail	Changes
1	April. 03, 2023	Detail

List of change history