UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006422 |
|---|---|
| Receipt number | R000007622 |
| Scientific Title | Effect of ramelteon improves nocturia in patients on insomnia with menopausal symptoms. |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2011/10/18 19:49:42 |
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Basic information
Public title
Effect of ramelteon improves nocturia in patients on insomnia with menopausal symptoms.
Acronym
Effect of ramelteon improves nocturia in patients with menopausal symptoms.
Scientific Title
Effect of ramelteon improves nocturia in patients on insomnia with menopausal symptoms.
Scientific Title:Acronym
Effect of ramelteon improves nocturia in patients with menopausal symptoms.
Region
| Japan |
Condition
Condition
nocturia
Classification by specialty
| Obstetrics and Gynecology | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of ramelteon reduced number of nocturia in patients on insomnia with menopausal symptoms.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
number of nocturia
Key secondary outcomes
SMI(Simplified Menopausal Index)
OABSS(Overactive bladder symptom score)
IPSS(International prostate symptom score)
PSQI(Pittsburgh Sleep Quality Index)
Safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Nocturia of 2 times or more
SMI 26 points or more
45-65 years old
Written informed consent
Key exclusion criteria
Patient with drug allergy
Severe liver dysfunction
During administration of Fluvoxamine maleate
Acute urinary tract infection
Physician deems inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoko Sakata |
Organization
Yokohama-City University Hospital
Division name
Urology
Zip code
Address
Fukuura3-9 Kanaza-ku Yokohama, Kanagawa Prefecture Japan
TEL
045-787-2679
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoko Sakata |
Organization
Yokohama-City University Hospital
Division name
Urology
Zip code
Address
Fukuura3-9 Kanaza-ku Yokohama, Kanagawa Prefecture Japan
TEL
045-787-2679
Homepage URL
Sponsor or person
Institute
The Urology department of Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama City University Hospital gynecology
Yokohama Medical Women's Ladies Clinic
Yoshikata Ladies Clinic
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
Resistration will start from October 2011
Management information
Registered date
| 2011 | Year | 09 | Month | 28 | Day |
Last modified on
| 2011 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007622
