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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012755
Receipt No. 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

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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
Email 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
Email y-kawabat@hotmail.co.jp

Sponsor
Institute Yokohama Sakae Kyosai Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014904

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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