UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of coagulability and coagulation factors before and after the development of symptoms in patients with physical urticaria
Title of the study (Brief title)	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	Michihiro Hide
Organization	Hiroshima University Hospital
Division name	Department of Dermatology
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	Satoshi Morioke
Organization	Hiroshima University Hospital
Division name	Department of Dermatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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