UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010020
Receipt number 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 15:05:29

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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 or person

Institute

Department of Dermatology, Integrated Health Sciences, Institute of Biomedical & Health Sciences, Hiroshima University

Institute

Department

Personal name



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

Value
https://center6.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