臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 05, 2021
Last modified on	Feb. 05, 2022
Trial ID	jRCT1031210223

Scientific Title	A prospective study examining patient satisfaction and sleep analysis data in drug therapy for patients with insomnia.
Public Title	A prospective study examining patient satisfaction and sleep analysis data in drug therapy for patients with insomnia.

Contact for Scientific Queries	Name	Sone Masayoshi
	Affiliation	Sone Clinic Shinjuku
	Address	3-32-8, Shinjuku, Shinjuku-ku, Tokyo
	Telephone	+81-3-3356-3888
	E-mail	chi-pr-cirb-sone@cmicgroup.com
Contact for Public Queries	Name	Watanabe Yosuke
	Affiliation	SUSMED, Inc
	Address	3-7-2, Nihonbashi-honcho, Chuo-ku, Tokyo
	Telephone	+81-335273593
	E-mail	support@susmed.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 05, 2021
Actual date of first enrollment		Aug. 12, 2021
Target sample size		17
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	Insomnia disorder (ICSD-3)
	Exclusion Criteria	1. Patients with Athens Insomnia Scale (AIS) at the getting consent or beginning of the trial less than 9 points. 2. Patients who have experienced drug treatment for insomnia within the past 14 days. 3. Patients without a sleeping diary since 7 days from the start of the trial, or Patients who do not need further improvement. 4. Patients suspected or suffering from the following diseases. Mental illness Sleep apnea syndrome Sleep-related movement disorder Central hypersomnia Accompanying sleep Circadian rhythm disturbance alcoholism drug addiction cancer immune disease 5. Pregnant women, lactating women 6. Patients who are engaged in jobs requiring driving such as automobiles or motorbikes or jobs involving danger or scheduled to participate during the trial participation period.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Insomnia disorder
Intervention(s)		Take zolpidem tartrate tablets 5 mg (Mysley tablets or its generic products) once daily before bedtime for 8 weeks
Health Condition(s) Keyword		Insomnia disorder
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Evaluation of Athens Insomnia Scale at 8 weeks from the start of treatment
Secondary Outcome(s)		CGI-I Percentage of patients with AIS of less than 6 points at completion of clinical trial medication after completion of clinical trial

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	SUSMED, Inc
Secondary Sponsor	Applicable

Name of Certified Review Board	Kitamachi Clinic Ethics Review Committee
Address	1-1-3, Kichijoji Kitamachi, Musashino City, Tokyo
Telephone	+81-70-5011-8550
E-Mail	chi-pr-ec-kitamachi@cmicgroup.com
Approval Status	Approval
Date of approval	July. 21, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 05, 2022	(this page)	Changes
2	Oct. 20, 2021	Detail	Changes
1	Aug. 05, 2021	Detail

List of change history