UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013808 |
|---|---|
| Receipt number | R000015966 |
| Scientific Title | Efficacy and safety of eszopiclone in the treatment of insomnia complicated with nocturnal awakenings associated with urination. |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2015/05/01 17:48:34 |
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Basic information
Public title
Efficacy and safety of eszopiclone in the treatment of insomnia complicated with nocturnal awakenings associated with urination.
Acronym
Effect of eszopiclone in insomnia with nocturia
Scientific Title
Efficacy and safety of eszopiclone in the treatment of insomnia complicated with nocturnal awakenings associated with urination.
Scientific Title:Acronym
Effect of eszopiclone in insomnia with nocturia
Region
| Japan |
Condition
Condition
Insomnia complicated with nocturnal awakenings associated with urination.
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficasy and safety of eszopiclone in the treatment of insomnia complicated with nocturnal awakenings associated with urination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)QOL for insomnia patients of sleep disorder
(2)Frequency of vonding at night
Key secondary outcomes
(1)Changes in Pittsburg Sleep Quality Index
(2)Volume of vonding at night
(3)The time from awakening to getting to sleep again
(4)The time from getting to sleep to
awakening first at night
(5)A questionnaire of comprehensive evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eszopiclone(1-3mg/day)
Interventions/Control_2
no therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with insomnia complicated with nocturnal awakenings associated with urination.
Key exclusion criteria
(1)hyper sensitive patients to eszopiclone or zopiclone
(2)myasthenia gravis
(3)acute narrow-angle glaucoma
(4)pulmonale,emphysema and during stage of acute asthma and cerebral vascular
disturbance several respiratory disability
(5)bladder cancer and prostate cancer
(6)Patients who received any prior therapeutic medication for OAB(over active bladder)
less than one month before entry
(7)Patients who received any prior therapeutic medication for BPH(being prostatic hypertrophy) less than six months before entry
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsui Tsuyoshi |
Organization
Department of medicine,School of Medicine, Nihon University
Division name
Division of Urology
Zip code
Address
30-1 Oyagushi Kamimachi,Itabashi-ku,Tokyo,Japan
TEL
03-3972-8111
matsui.tsuyoshi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hodota Emiko |
Organization
Department of medicine,School of Medicine, Nihon University
Division name
Division of Urology
Zip code
Address
30-1 Oyagushi Kamimachi,Itabashi-ku,Tokyo,Japan
TEL
03-3972-8111
Homepage URL
hodota.emiko@nihon-u.ac.jp
Sponsor or person
Institute
Department of medicine,School of Medicine, Nihon University
Institute
Department
Personal name
Funding Source
Organization
No
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
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 25 | Day |
Last modified on
| 2015 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015966
