UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005119 |
|---|---|
| Receipt number | 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 13:46:43 |
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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
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
Sponsor or person
Institute
Oita University, Faculty of medicine
Dept of clin pharmacol & ther
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006085
