UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005744 |
|---|---|
| Receipt number | R000006783 |
| Scientific Title | The effect of melatonin or ramelteon for patients with circadian rhythm sleep disorder. |
| Date of disclosure of the study information | 2011/06/13 |
| Last modified on | 2011/06/08 09:32:46 |
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Basic information
Public title
The effect of melatonin or ramelteon for patients with circadian rhythm sleep disorder.
Acronym
The effect of melatonin or ramelteon for patients with circadian rhythm sleep disorder.
Scientific Title
The effect of melatonin or ramelteon for patients with circadian rhythm sleep disorder.
Scientific Title:Acronym
The effect of melatonin or ramelteon for patients with circadian rhythm sleep disorder.
Region
| Japan |
Condition
Condition
circadian rhythm sleep disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of ramelteon in patients with circadian rhythm sleep disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
sleep-onset time, wakeup time, slee ptime, dim light meratonin onsettime
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
ramelteon administration(4mg, once a day, 7h bofore average sleep-onset time)
Interventions/Control_2
melatonin administration (1mg, once a day, 7h bofore average sleep-onst time)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with circadian rhythm sleep disorder diagnosed by International Crassification of Sleep Disorders.
Key exclusion criteria
Patients with active co-morbidities including severe conditions.
Heart failure, liver failure, renal failure, severe infection.
Pregnancy, breast feeding and suspected pregnancy.
Under treatment of Fluvoxamine Maleate.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Kamei |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Laboratory Medicine
Zip code
Address
4-1-1, Ogawahigasicho, Tokyo,187-8551
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Kamei |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Laboratory Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 06 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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
| 2011 | Year | 06 | Month | 08 | Day |
Last modified on
| 2011 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006783
