臨床研究等提出・公開システム

Date of registration	Sept. 30, 2019
Last modified on	Mar. 03, 2020
Trial ID	jRCT1080224896

Scientific Title	Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #4
Public Title	Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #4

Completion Date or Terminated date	Feb. 11, 2020
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Taisho Pharmaceutical Co.Ltd
	Address	3-24-1,Takada,Toshima-ku,Tokyo JAPAN
	Phone Number	-
	E-mail Address	clinical-trials@taisho.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Taisho Pharmaceutical Co.Ltd
	Address	3-24-1,Takada,Toshima-ku,Tokyo JAPAN
	Phone Number	-
	E-mail Address	clinical-trials@taisho.co.jp

Recruitment Status	completed

Date of First Enrolment		Oct. 07, 2019
Target Sample Size		26
Study Type		Interventional
Study Design	Study Design	Intervention study
Study Design	Objective	other
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	-Body mass index (BMI) equal and more than 18.5, and less than 25.0 kg/m^2 at screening inspection -No visual impairment (enable to correct the vision with eyeglasses or contact lens) -Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study -Other protocol defined inclusion criteria could apply
	Exclusion Criteria	-History of drug and food allergy -Hypersensitivity to zopiclone -Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator -Other protocol defined inclusion criteria could apply
	Minimum Age	21age old over
	Maximum Age	64age old under
	Gender	Male
Health Condition or Problem Studied		Japanese healthy adult male participants
Intervention(s)		investigational material(s) Generic name etc : Zopiclone INN of investigational material : Zopiclone Therapeutic category code : 112 Hypnotics and sedatives, antianxietics Dosage and Administration for Investigational material : 7.5 mg, orally, once before going-to-bed control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : 7.5 mg, orally, once before going-to-bed
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		other Standard Deviation of Lateral Position
Secondary Outcome		other Inappropriate Line Crossing

Primary Sponsor	Taisho Pharmaceutical Co.Ltd
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku Fukuoka 812-0025 Japan
Phone Number	+81-92-283-7701
E-mail Address
Status of Review	Approval
Date of Approval	Oct. 04, 2019

Secondary ID No.	NCT04108351
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194981
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	Mar. 03, 2020	(this page)	Changes
2	Oct. 11, 2019	Detail	Changes
1	Oct. 01, 2019	Detail

List of change history