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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007737
Receipt No. 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

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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
Email 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
Email k2osada@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School Of Medicine
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009102

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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