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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009247
Receipt No. R000010857
Scientific Title The effect of histamine on sudomotor function
Date of disclosure of the study information 2012/11/01
Last modified on 2018/12/31

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Basic information
Public title The effect of histamine on sudomotor function
Acronym The effect of histamine on sudomotor function
Scientific Title The effect of histamine on sudomotor function
Scientific Title:Acronym The effect of histamine on sudomotor function
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the factor associated with anhidrosis
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes axon reflex-mediated sweating volume
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 acethylcholine
Interventions/Control_2 acethylcholine+histamine
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 written informed concent
Key exclusion criteria - The part-time-service personnel, a fixed-term employment person
- subjects whose consent was not obtained
- glaucoma which has acetylcholine hypersensitivity, cholinergic urticaria, and asthma, the thing which has prostatic hypertrophy, a pregnant woman, the woman under breast-feeding
- Who has a certain dermatological lesion in examination region
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Murota
Organization Osaka university
Division name Dermatology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka
TEL 0668795111
Email h-murota@derma.med.osaka-u.ac.jp

Public contact
1st 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
Email h-murota@derma.med.osaka-u.ac.jp

Sponsor
Institute Depatment of Dermatology, Osaka University
Institute
Department

Funding Source
Organization Depatment 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
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
2012 Year 11 Month 01 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 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 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
2012 Year 11 Month 01 Day
Last modified on
2018 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010857

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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