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

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 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


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

Value
https://center6.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