UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023690 |
|---|---|
| Receipt number | 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 14:23:03 |
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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
| Obstetrics 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
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
teragyne@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027282
