UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012755 |
|---|---|
| Receipt number | R000014904 |
| Scientific Title | Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke |
| Date of disclosure of the study information | 2014/01/04 |
| Last modified on | 2015/03/03 17:31:03 |
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Basic information
Public title
Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke
Acronym
Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke
Scientific Title
Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke
Scientific Title:Acronym
Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We intend for the patients with sleep disturbance in acute stroke and assess the effect of ramelteon on sleep disturbance and restlessness by controlling the sleep-wake cycle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Richmond agitation sedation scale two weeks after intervention
Key secondary outcomes
sleep condition/ insomnia/ daytime somnolence/ administration of sedative medication, psychotropic medication and sleep medication except for ramelteon/ body restraint/ fall/ modified Rankin Scale/ adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration group:ramelteon 8mg, just before sleep, daily
Interventions/Control_2
Non-administration group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who were hospitalized for a stroke acute phase and experienced sleep disruption
Key exclusion criteria
1.Patients taking ramelteon at the time of admission
2.Patients with contraindication for ramelteon (known hypersensitivity to remelteon, a history of severe liver/hepatic dysfunction, patients taking fluvoxamine maleate)
3.Patients who were not able to take drug both orally and through the tube
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Kawabata |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Neurology and Stroke Medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa, Japan
TEL
045-891-2171
y-kawabat@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Kawabata |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Neurology and Stroke Medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa, Japan
TEL
045-891-2171
Homepage URL
y-kawabat@hotmail.co.jp
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital
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
横浜栄共済病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | 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
| 2014 | Year | 01 | Month | 04 | Day |
Last modified on
| 2015 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014904
