UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007737 |
|---|---|
| Receipt number | R000009102 |
| Scientific Title | Examination of the efficacy of melatonin receptor agonist, ramelteon to the sleep disturbance |
| Date of disclosure of the study information | 2012/10/31 |
| Last modified on | 2017/04/17 16:28:55 |
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Basic information
Public title
Examination of the efficacy of melatonin receptor agonist, ramelteon to the sleep disturbance
Acronym
Examination of the efficacy of melatonin receptor agonist, ramelteon to the sleep disturbance
Scientific Title
Examination of the efficacy of melatonin receptor agonist, ramelteon to the sleep disturbance
Scientific Title:Acronym
Examination of the efficacy of melatonin receptor agonist, ramelteon to the sleep disturbance
Region
| Japan |
Condition
Condition
Patients with primary insomnia and the circadian rhythm sleep disorder is diagnosed with the DSM diagnostic criteria and has it or more 6 points of Pittsburgh Sleep Quality Index
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We compare the effect on insomnia in two groups, one is the ramelteon was taken befor bedtime, the other is approximately one hour after the supper back
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
Sleep scan
Key secondary outcomes
clock gene RNA expression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group of oral administration approximately one hour after the supper back at 8 mg of ramelteon once once a day
Interventions/Control_2
The group of oral administration before bedtime at 8 mg of ramelteon once once a day
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with insomnia that primary insomnia and circadian rhythm sleep disorder are diagnosed with the DSM diagnostic criteria and have it or more 6 points of Pittsburgh Sleep Quality Index
Key exclusion criteria
The patients with a history of hypersensitivity for ramelteon
The patients with serious hepatic disorder
The patients receiving the fluvoxamine
The women with during the pregnancy or the possibility to pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School Of Medicine
Division name
Neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
k2osada@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School Of Medicine
Division name
Neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
Homepage URL
k2osada@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School Of Medicine
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
| 2012 | Year | 10 | Month | 31 | 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
| 2012 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 11 | 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
| 2012 | Year | 04 | Month | 13 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009102
