UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010476 |
|---|---|
| Receipt number | R000012246 |
| Scientific Title | A randomized, double blind, placebo-controlled trial of Oxibarrier. |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2016/04/13 10:10:43 |
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Basic information
Public title
A randomized, double blind, placebo-controlled trial of Oxibarrier.
Acronym
A randomized, double blind, placebo-controlled trial of Oxibarrier.
Scientific Title
A randomized, double blind, placebo-controlled trial of Oxibarrier.
Scientific Title:Acronym
A randomized, double blind, placebo-controlled trial of Oxibarrier.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of taking Oxibarrier on sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Sleep log
(2) Athens Insomnia Scale
Key secondary outcomes
(3) Actigraph
(4) Pittsburgh sleep quality index
(5) SF-8 acute
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Taking Oxibarrier for two weeks, and then taking Placebo for two weeks after wash-out for two weeks.
Interventions/Control_2
Taking Placebo for two weeks, and then taking Oxibarrier for two weeks after wash-out for two weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) subjective complaint of difficulties initiating (sleep latency >30 min) or maintaining sleep (time awake after sleep onset >30 min) for a month.
(2) general good health without evidence of clinically significant disease as determined by medical history, physical examination, and urine drug screens.
(3) The score of Pittsburgh sleep quality index: 5-8
Key exclusion criteria
(1) disease that could affect the action of the study
(2) current or past history of serious, severe, or unstable physical (eg, congestive heart failure, chronic obstructive pulmonary disease, diabetes, thyroid disease) or psychiatric illness (eg, major depression, generalized anxiety disorder)
(3) evidence of another sleep disorder (eg, sleep apnea, restless legs syndrome, periodic limb movements), irregular sleep patterns, or occupations involving evening or night shift work
(4) allergies or suspected intolerance to the study medications or any antihistamines
(5) current use of substances or medications known to affect sleep, including prescription psychotropics, sedatives, hypnotics, nicotine-replacement therapies, over-the-counter
sleep aids, or herbal products
(6) current or recent (within 1 year) alcohol or drug abuse
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Inoue |
Organization
Tokyo Medical University
Division name
Department of Somnology
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku, Tokyo
TEL
03-3351-6141
yuinoue@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Komada |
Organization
Tokyo Medical University
Division name
Department of Somnology
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku, Tokyo
TEL
03-3351-6141
Homepage URL
http://www.tokyo-med.ac.jp/sleep/
ykoma@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Somnology, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
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 | 07 | Month | 01 | 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
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2016 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012246
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
