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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005119
Receipt No. R000006085
Scientific Title Study of the effect of sublingual sleeping agent with taste masking on the subjective symptoms in humans.
Date of disclosure of the study information 2011/03/14
Last modified on 2012/07/02

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Basic information
Public title Study of the effect of sublingual sleeping agent with taste masking on the subjective symptoms in humans.
Acronym Study of the effect of sublingual sleeping agent with taste masking on the subjective symptoms in humans.
Scientific Title Study of the effect of sublingual sleeping agent with taste masking on the subjective symptoms in humans.
Scientific Title:Acronym Study of the effect of sublingual sleeping agent with taste masking on the subjective symptoms in humans.
Region
Japan

Condition
Condition ahypnosis
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to study the subjective symptoms after sublingual administration
Basic objectives2 Others
Basic objectives -Others taste and olfactory sense
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes subjective symptoms
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 active drug with taste masking
Interventions/Control_2 active drug without taste masking
Interventions/Control_3 placebo with taste masking
Interventions/Control_4 placebo without taste masking
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
40 years-old >=
Gender Male and Female
Key inclusion criteria capable of understanding and adhering to the protocol
Key exclusion criteria impairment of taste
liver dysfunction
renal dysfunction
ECG abnormality
drug dependence
drug allergy
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromitsu Imai
Organization Oita University, Faculty of medicine
Division name Dept of clinical pharmacology and therapeutics
Zip code
Address 1-1 Idaigaoka Hasama Yufu-city, Oita, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Oita university, Faculty of medicine
Division name Dept of clinical pharmacology and therapeutics
Zip code
Address 1-1 Idaigaoka Hasama Yufu-city, Oita, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Oita University, Faculty of medicine
Dept of clin pharmacol & ther
Institute
Department

Funding Source
Organization Takeda pharmaceutical company
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
2011 Year 03 Month 14 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 02 Month 03 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
2011 Year 02 Month 21 Day
Last modified on
2012 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006085

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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