UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027787 |
|---|---|
| Receipt number | R000031809 |
| Scientific Title | Exploratory study to examine the effect of Ramelteon on end of life delirium |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2018/12/20 16:23:11 |
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Basic information
Public title
Exploratory study to examine the effect of Ramelteon on end of life delirium
Acronym
Exploratory study to examine the effect of Ramelteon on end of life delirium
Scientific Title
Exploratory study to examine the effect of Ramelteon on end of life delirium
Scientific Title:Acronym
Exploratory study to examine the effect of Ramelteon on end of life delirium
Region
| Japan |
Condition
Condition
Advanced cancer
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether Ramelteon has a preventive effect on end of life delirium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of delirium in a week
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Ramelteon 8mg/day
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. In palliative care unit
2. Possible to take medicine orally
3. Cancer associated pain is well controlled
4. Life expectancy is shorter than 1 months
5. Written informed consent
Key exclusion criteria
1. Having regular use of antipsychotics, antidepressants, antimanics and anticonvulsants.
2. Dementia
3. Serious complications such as liver failure, respiratory insufficiency, heart failure, or renal failure
4. Alcoholism or psychiatric patients
5. Already diagnosed delirium
6. Symptomatic intracranial lesions
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Inoue |
Organization
Tohoku University School of Medicine
Division name
Department of Palliative Medicine
Zip code
Address
2-1, Seiryocho, Aobaku, Sendai
TEL
022-717-7366
akira.inoue.b2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Hiratsuka |
Organization
Tohoku University School of Medicine
Division name
Department of Palliative Medicine
Zip code
Address
2-1, Seiryocho, Aobaku, Sendai
TEL
022-717-7366
Homepage URL
yusuke.hiratsuka.e6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University School of Medicine, Department of Palliative Medicine
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | 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
Management information
Registered date
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031809
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
