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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002585
Receipt No. R000002948
Scientific Title Analysis of coagulability and coagulation factors before and after the development of symptoms in patients with physical urticaria
Date of disclosure of the study information 2009/10/05
Last modified on 2018/05/07

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Basic information
Public title Analysis of coagulability and coagulation factors before and after the development of symptoms in patients with physical urticaria
Acronym Coagulability and coagulation factors before and after the development of urticaria
Scientific Title Analysis of coagulability and coagulation factors before and after the development of symptoms in patients with physical urticaria
Scientific Title:Acronym Coagulability and coagulation factors before and after the development of urticaria
Region
Japan

Condition
Condition physical urticaria
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the involvement of the coagulation pathway in the pathogenesis of physical urticaria, we investigate coagulability, coagulation factors and levels of blood histamine before and after the development of symptoms in patients with physical urticaria.
Basic objectives2 Others
Basic objectives -Others Investigation of the pathogenesis
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurements regarding coagulability, coagulation factors and levels of blood histamine before and after the development of symptoms
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 The provocation of urticarial symptoms
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 Patients with physical urticaria who
1. are not less than 20 years old (no upper limit)
2. gave written informed consent
Key exclusion criteria 1. Pregnant or lactating women or women of child bearing potential not using contraception
2. Patients with diseases as follows. Liver disease, psychological illness, convulsive and other seizure, heart disease, hemoglobinopathy, hemophilia, uncontrolled diabetes, and autoimmune diseases.
3. Patients who use medications that influence the coagulation and fibrinolytic cascade.
4. Others whom the physician judges are not suitable as subjects
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michihiro Hide
Organization Hiroshima University Hospital
Division name Department of Dermatology
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551
TEL 082-257-5237
Email ed1h-w1de-road@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Morioke
Organization Hiroshima University Hospital
Division name Department of Dermatology
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551
TEL 082-257-5237
Homepage URL
Email morioke-hma@hiroshima-u.ac.jp

Sponsor
Institute Department of Dermatology, Hiroshima University Hospital
Institute
Department

Funding Source
Organization Self funding
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
2009 Year 10 Month 05 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 Terminated
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 22 Day
Last follow-up date
2018 Year 05 Month 08 Day
Date of closure to data entry
2018 Year 05 Month 08 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 05 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002948

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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