UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025514
Receipt No. R000029296
Scientific Title Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Date of disclosure of the study information 2017/01/05
Last modified on 2017/01/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Acronym Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Scientific Title Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Scientific Title:Acronym Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Region
Japan

Condition
Condition Insomnia in patients with obstructive sleep apnea syndrome.
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine safety of ramelteon, which is free of muscle relaxing effect unlike other sleeping drugs, for patients with obstructive sleep apnea syndrome
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Apnea hypopnea index after administration of ramelteon for 3 weeks
Key secondary outcomes Sleep latency after administration of ramelteon for 3 weeks

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
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 Oral administration of ramelteon (21 days) -> Polysomnography -> Oral administration of placebo (21 days) -> Polysomnography
Interventions/Control_2 Oral administration of placebo (21 days) -> Polysomnography -> Oral administration of ramelteon (21 days) -> Polysomnography
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient with insomnia who has 3% ODI(Oxygen Desaturation Index) higher than 40/hr
Key exclusion criteria 1) Patient who already takes a sleeping drug
2) Patient who want to take a sleeping drug immediately
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makiko Kumamoto
Organization Nara Medical University
Division name Second Department of Internal Medicine
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email mkuma@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Kumamoto
Organization Nara Medical University
Division name Second Department of Internal Medicine
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email mkuma@naramed-u.ac.jp

Sponsor
Institute Second Department of Internal Medicine, Nara Medical University
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 奈良県立医科大学附属病院(奈良県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 05 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 Completed
Date of protocol fixation
2012 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 04 Day
Last modified on
2017 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029296

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.