UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006711 |
|---|---|
| Receipt number | R000007932 |
| Scientific Title | Randomized controlled trials of ramelteon treatment for nocturia with sleep disorders after treatment for prostate cancer brachytherapy. |
| Date of disclosure of the study information | 2011/11/12 |
| Last modified on | 2011/11/11 23:38:37 |
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Basic information
Public title
Randomized controlled trials of ramelteon treatment for nocturia with sleep disorders after treatment for prostate cancer brachytherapy.
Acronym
Randomized controlled trials of ramelteon treatment for nocturia with sleep disorders after treatment for prostate cancer brachytherapy.
Scientific Title
Randomized controlled trials of ramelteon treatment for nocturia with sleep disorders after treatment for prostate cancer brachytherapy.
Scientific Title:Acronym
Randomized controlled trials of ramelteon treatment for nocturia with sleep disorders after treatment for prostate cancer brachytherapy.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and tolerability of additional ramelteon treatment for nocturia with sleep disorders after treatment for prostate cancer brachytherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
number of nocturia
Key secondary outcomes
IPSS, OABSS, PSQI, Safety
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
Sleep instruction
Interventions/Control_2
Sleep instruction + Oral ramelteon 8mg
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
Key inclusion criteria
1)For prostate cancer treatment brachytherapy has been performed.
2)Nocturia of 2 times or more
3)20 years old and more
4)Although alpha-1 blocker is used, there is frequent nocturia.
5)Written informed consent
Key exclusion criteria
1)Patient with drug allergy
2)Severe liver dysfunction
3)During administration of Fluvoxamine maleate
4)Acute urinary tract infection
5)Physician deems inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroji Uemura |
Organization
Yokohama city university school of medicine
Division name
Department of urology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kawahara |
Organization
Yokohama city university school of medicine
Division name
Department of urology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
Yokohama city university school of medicine department of urology
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 11 | Month | 12 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 11 | Day |
Last modified on
| 2011 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007932
