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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003881
Receipt No. R000004672
Scientific Title Efficacy of ramelteon for nocturia
Date of disclosure of the study information 2010/09/01
Last modified on 2011/10/03

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Basic information
Public title Efficacy of ramelteon for nocturia
Acronym Efficacy of ramelteon for nocturia
Scientific Title Efficacy of ramelteon for nocturia
Scientific Title:Acronym Efficacy of ramelteon for nocturia
Region
Japan

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

Objectives
Narrative objectives1 To assess whether ramelteon improves sleep quality of nocturic patiens.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes improvement of global score of the Pittsburgh sleep quality index
Key secondary outcomes improvement of other questionnaire, improvement of objective parameters on frequency-volume charts, safety of ramelteon

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 life style measure
Interventions/Control_2 oral administration of ramelteon
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 2 or more of nocturia score in the International Prostate Symptom Score
Key exclusion criteria 1) patiens with definite neurogenic bladder, 2) patients with definite organic disorders in lower urinary tract, 3) patients undergoing insomnia treatment, 4) patients receiving fluvoxamine maleate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Ogawa
Organization Kyoto University Graduate School of Medicine
Division name Urology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Graduate School of Medicine
Division name Urology
Zip code
Address
TEL
Homepage URL
Email ky7527@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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
2010 Year 09 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
Furosemide treatment definitively improved nocturia with nocturnal polyuria. GJG treatment may also induce mild improvement of nocturnal polyuria, although further study is required to confirm its efficacy.
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 Completed
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 06 Day
Last modified on
2011 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004672

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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