UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to investigate the efficacy of warfarin for intractable urticaria
Title of the study (Brief title)	Clinical study to investigate the efficacy of warfarin for intractable urticaria
Region	Japan

Condition
Condition	Urticaria
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy, safety, and doses of warfarin for intractable urticaria
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptoms and Urticarial scores before and after taking warfarin
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Warfarin
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	A) Patients who are suffuring from urticaria and are 20 years old or more and less than 70 years old. B) Patients who are insufficiently controlled by standard therapies, or are not able to use standard medicines due to the adverse effects. C) Patients who can come to our outpatient clinic. D) Patients who can give consent in writing.
Key exclusion criteria	A) Patiets who take medical agents that influence on coagulation system. B) Bleeding patients. C) Patients who has the risks of bleeding. E) Patients who are recently operated or injured. F) Patients who previously had the adverse drug reaction against warfarin. And patients who can not stop taking medications which show drug interaction with warfarin. G) Patients who are pregnant or have chance of pregnancy. H) Patients who are medicated by vitamineK. I) Patiens who are pegged as unsuitable for this study by their doctor. J) Patients who has the potential of injury or contused wound by heavy exercise or work.
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, Integrated Health Sciences, Institute of Biomedical & Health Sciences, Hiroshima University
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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 26 Day
Anticipated trial start date	2013 Year 02 Month 18 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 06 Month 30 Day
Date trial data considered complete	2017 Year 06 Month 30 Day
Date analysis concluded	2017 Year 06 Month 30 Day

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

Management information
Registered date	2013 Year 02 Month 12 Day
Last modified on	2017 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010724