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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004873
Receipt No. R000005800
Scientific Title Clinical study of the efficacy of ramelteon and zopiclone for nocturia
Date of disclosure of the study information 2011/01/14
Last modified on 2011/01/13

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Basic information
Public title Clinical study of the efficacy of ramelteon and zopiclone for nocturia
Acronym Clinical study of the efficacy of ramelteon and zopiclone for nocturia
Scientific Title Clinical study of the efficacy of ramelteon and zopiclone for nocturia
Scientific Title:Acronym Clinical study of the efficacy of ramelteon and zopiclone for nocturia
Region
Japan

Condition
Condition nocturia
Classification by specialty
Psychiatry Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to detect the efficacy of ramelteon and zopiclone for nocturia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes night time urinary frequency
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ramelteon
Interventions/Control_2 zopiclone
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) over 2 times of urinary frequency for night time
Key exclusion criteria 1) past history of insomnia
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhide Kitagawa
Organization Kanazawa University
Division name Department of Urology
Zip code
Address Takaramachi, Kanazawa
TEL 076-265-2393
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa University
Division name Department of Urology
Zip code
Address
TEL
Homepage URL
Email yasukita@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Department of Urology, Kanazawa university
Organization
Division
Category of Funding Organization Other
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
2011 Year 01 Month 14 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 Enrolling by invitation
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 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
2011 Year 01 Month 13 Day
Last modified on
2011 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005800

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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