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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010020
Receipt No. R000010724
Scientific Title Clinical study to investigate the efficacy of warfarin for intractable urticaria
Date of disclosure of the study information 2013/02/18
Last modified on 2017/08/17

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Basic information
Public title Clinical study to investigate the efficacy of warfarin for intractable urticaria
Acronym Clinical study to investigate the efficacy of warfarin for intractable urticaria
Scientific Title Clinical study to investigate the efficacy of warfarin for intractable urticaria
Scientific Title:Acronym 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
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, 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)

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 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

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
2013 Year 01 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010724

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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