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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010476
Receipt No. 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

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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
Email 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/
Email ykoma@tokyo-med.ac.jp

Sponsor
Institute Department of Somnology, Tokyo Medical University
Institute
Department

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
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
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
URL(English) https://upload.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
Registered date File name


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