UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012632 |
|---|---|
| Receipt number | R000014774 |
| Scientific Title | Effect of ramelteon to mild to moderate sleep apnea |
| Date of disclosure of the study information | 2013/12/19 |
| Last modified on | 2013/12/19 22:35:38 |
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Basic information
Public title
Effect of ramelteon to mild to moderate sleep apnea
Acronym
Ramelteon for sleep apnea
Scientific Title
Effect of ramelteon to mild to moderate sleep apnea
Scientific Title:Acronym
Ramelteon for sleep apnea
Region
| Japan |
Condition
Condition
Sleep apnea
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sleep medication is usually worsening to the patients with Sleep apnea. Butnewly developed rametelon may not worthen those patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
height
Body weight
Apnea Hyopnea Index (AHI)
Blood pressure
Key secondary outcomes
none
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ramelteon were taken to the patients with sleep apnea.
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients with mild to moderate sleep apnea
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Ukimura |
Organization
Osaka medical college
Division name
General Internal Medicine
Zip code
Address
2-7 Daigakucho Takatsuki Osaka
TEL
81726831221
in3011@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Kanzaki |
Organization
Osaka medical college
Division name
General Internal Medicine
Zip code
Address
2-7 Daigakucho Takatsuki Osaka
TEL
81726831221
Homepage URL
in3089@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Osaka medical college
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
| 2013 | Year | 12 | Month | 19 | 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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2013 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014774
