UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010206
Receipt number R000011955
Scientific Title A questionnaire survey on the patient's subjective symptoms and the treatment reality of chronic urticaria treatment.
Date of disclosure of the study information 2013/03/11
Last modified on 2014/04/22 16:50:34

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Basic information

Public title

A questionnaire survey on the patient's subjective symptoms and the treatment reality of chronic urticaria treatment.

Acronym

Chronic urticaria treatment survey.

Scientific Title

A questionnaire survey on the patient's subjective symptoms and the treatment reality of chronic urticaria treatment.

Scientific Title:Acronym

Chronic urticaria treatment survey.

Region

Japan


Condition

Condition

Chronic urticaria

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1.To find out the reality of the treatment for chronic urticaria
2.To find out how satisfied the patients are about the treatment for chronic urticaria

Basic objectives2

Others

Basic objectives -Others

Actual condition survey

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Treatment method for chronic urticaria
2.The degree of satisfaction on treatment for chronic urticaria

Key secondary outcomes

Behavior for receiving treatment for chronic urticaria


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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 who were diagnosed as chronic urticaria aged 20 or over.

Key exclusion criteria

Patients aged 19 or under.
Patients who do not have chronic urticaria.

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Kawashima/Yoshiki Miyachi

Organization

Tokyo Woman's Medical University/
Kyoto University Graduate School of Medicine

Division name

Dermatology/Dermatology

Zip code


Address

8-1 Kawada-cho,Shinjyuku-ku,Tokyo 162-8666,Japan/Yoshidakonoecho Kyoto Sakyo-ku, Kyoto 606-8315,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

EBMs Co.,Ltd

Division name

Business Strategy Division

Zip code


Address

World Trade Center Bldg. 24F

TEL


Homepage URL


Email



Sponsor or person

Institute

Non-Profit Organization Health Institute Research of Skin

Institute

Department

Personal name



Funding Source

Organization

Non-Profit Organization Health Institute Research of Skin

Organization

Division

Category of Funding Organization

Other

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

2013 Year 03 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2012 Year 12 Month 26 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1.Treatment method for chronic urticaria
2.The degree of satisfaction on treatment for chronic urticaria
3.Behavior for receiving treatment for chronic urticaria


Management information

Registered date

2013 Year 03 Month 11 Day

Last modified on

2014 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011955


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name