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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013808
Receipt No. 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

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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
Email 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
Email hodota.emiko@nihon-u.ac.jp

Sponsor
Institute Department of medicine,School of Medicine, Nihon University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015966

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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