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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024462
Receipt No. R000028151
Scientific Title Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients
Date of disclosure of the study information 2016/10/18
Last modified on 2018/08/22

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Basic information
Public title Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients
Acronym Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients(LUN 1001)
Scientific Title Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients
Scientific Title:Acronym Evaluation of withdrawal symptoms and prognosis of eszopiclone - treated chronic insomnia patients(LUN 1001)
Region
Japan

Condition
Condition chronic insomnia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Withdrawal symptoms are evaluated in chronic insomnia patients with eszopiclone for 24 weeks by using withdrawal symptom evaluating questionnaires, furthermore, factors which influence withdrawal symptoms are examined in an exploring manner.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mean/median of sleep withdrawal symptoms questionnaire
Key secondary outcomes (1) sleeping drug withdrawal syndrome incidence
(2) Means/medians of ISI, SF-8 and Bendep-SRQ SV
(3) Factors which correlate with sleep withdrawal symptoms questionnaire
(e.g. ISI, SF-8, Bendep-SRQ SV, Population dynamics, etc.)
(4) Factors which correlate with ISI, SF-8 in the 24th week
(e.g. ISI,SF-8 in the 4th week, Population dynamics, etc.)
(5) Remission rate end of 2 weeks administration

<Safety>
Number and incidence of adverse events and the expression number of side effects, incidence


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 I give 2 mg of Eszopiclone once orally before going to bed.
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1)Patients meeting ICSD-III criteria for chronic insomnia
(2)Patients whose informed consent is obtained and patients capable of visits once a month
(3)Patients aged 20 years - less than 65 years at obtaining informed consent (non-elderly patients)
Key exclusion criteria (1)Patients taking hypnotics within two weeks before registration
(2)Patient having or having anamnestic history of following diseases, risk of suicide, (mild)manic episode, post-traumatic stress disorder, alcohol dependency and abuse, drug(non-alcoholic) dependency and abuse, anorexia nervosa, bulimia nervosa, antisocial personality disorder
(3)Patients with drug-induced insomnia
(4)Patients with other sleep disorders (circadian rhythm disorder, restless legs syndrome, periodic limb movement disability, sleep apnea syndrome, etc.)
(5)Patients with symptoms such as pain, fever, diarrhea, frequent urination, and coughs that remarkably disturbs sleep
(6)Patients under unstable condition of underlying disease that causes insomnia for 4 weeks before obtaining informed consent
(7)Patients with possibility of organic mental disorder
(8)Patients who are engaged in driving a car or operating a risky machine
(9)Patients of shift work workers and patients with jet lag
(10)Patients with anamnestic history of hypersensitivity for eszopiclone or zopiclone
(11)Patient with myasthenica gravis
(12)Patients with acute narrow-angle glaucoma
(13)Patients with highly impaired respiratory function by pulmonary heart, emphysema, bronchial asthma or acute phase of cerebrovascular disorders
(14)Patients who are determined unsuitable by principal investigators
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Inoue
Organization Yoyogi Sleep Disorder Center
Division name NA
Zip code
Address 1-24-10,Yoyogi,shibuya-ku,Tokyo151-0053,
TEL 03-3374-9112
Email inoue@somnology.com

Public contact
Name of contact person
1st name
Middle name
Last name Kiyomi Ishii
Organization APO PLUS STATION Co.,LTD
Division name Clinical Study Dept.CRO Business Div
Zip code
Address 2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027 Japan
TEL 03-6386-8800
Homepage URL
Email lun1001@apoplus.co.jp

Sponsor
Institute Yoyogi Sleep Disorder Center
Institute
Department

Funding Source
Organization Eisai Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2016 Year 10 Month 18 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
2016 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 20 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 18 Day
Last modified on
2018 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028151

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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