UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003881 |
|---|---|
| Receipt number | R000004672 |
| Scientific Title | Efficacy of ramelteon for nocturia |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2011/10/03 17:10:25 |
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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
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
ky7527@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004672
