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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023690
Receipt No. R000027282
Scientific Title long-term effectiveness of eszopiclone on chronic insomina disorder in middle-aged women
Date of disclosure of the study information 2016/10/01
Last modified on 2016/08/19

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Basic information
Public title long-term effectiveness of eszopiclone on chronic insomina disorder in middle-aged women
Acronym long-term effectiveness of eszopiclone on chronic insomina disorder in middle-aged women
Scientific Title long-term effectiveness of eszopiclone on chronic insomina disorder in middle-aged women
Scientific Title:Acronym long-term effectiveness of eszopiclone on chronic insomina disorder in middle-aged women
Region
Japan

Condition
Condition menopausal symptoms/chronic insomnia disorder
Classification by specialty
Obsterics and gynecology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of eszopiclone on subjective and objective sleep parameters in middle-aged women with chronic insomnia disorder
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes in objective sleep parameters measured by actigraphy after 12 and 24 weeks of treatment
Key secondary outcomes changes in Pittsburgh Sleep Quality Index, Athens Insomnia Scale, Epworth Sleepiness Scale, St. Marys Hospital Sleep Questionnaire, Menopause Health Related Quality of Life Questionnaire, and Hospital Anxiety and Depression Scale after 12 and 24 weeks of treatment

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 24-week treatment with 2 mg/day of eszopiclone
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
40 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria patients who have subjective insomnia scoring 6 or more on the Athens Insomnia Scale and are diagnosed with chronic insomnia disorder by ICSD-3 defnition
Key exclusion criteria women who are already treated with estrogens, antidepressants, anxiolytics, hypnotics etc. that are supposed to have effects on insomnia symptoms in middle-aged women
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Terauchi
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Zip code
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL 03-5803-4605
Email teragyne@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Terauchi
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Zip code
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL 03-5803-4605
Homepage URL
Email teragyne@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
2016 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 19 Day
Last modified on
2016 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027282

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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