UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010077 |
|---|---|
| Receipt number | R000011805 |
| Scientific Title | The effect of histamine on acethylcholine-mediated sweating |
| Date of disclosure of the study information | 2013/02/19 |
| Last modified on | 2018/12/31 09:28:23 |
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Basic information
Public title
The effect of histamine on acethylcholine-mediated sweating
Acronym
The effect of histamine on sweating
Scientific Title
The effect of histamine on acethylcholine-mediated sweating
Scientific Title:Acronym
The effect of histamine on sweating
Region
| Japan |
Condition
Condition
Healthy volunteers who were enrolled to this study after they signed an informed consent form and provided written and oral information to the study physicians.
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effect of histamine on sweating
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) axon-reflex mediated sweating volume
2) latency time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
with or without histamine
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with signed an informed consent form and provided written and oral information to the study physicians.
Key exclusion criteria
- The part-time-service personnel, a fixed-term employment person
- Whose consent was not obtained
-Subjects with glaucoma, cholinergic urticaria, asthma, prostatic hypertrophy, a pregnant woman, the woman under breast-feeding
-Subjects with dermatoses in a test lesion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Murota |
Organization
Osaka university, School of medicine
Division name
Dermatology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
0668795111
h-murota@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | 0668795111 |
Organization
Osaka univeristy
Division name
Dermatology
Zip code
Address
2-2, yamadaoka, suita
TEL
0668795111
Homepage URL
h-murota@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Dept. of dermatology, Osaka university
Institute
Department
Personal name
Funding Source
Organization
Dept. of dermatology, Osaka university
Organization
Division
Category of Funding Organization
Self funding
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 | 02 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 11 | 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 | 02 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011805
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
