UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008062
Receipt number R000009499
Scientific Title A study evaluating efficacy of non-sedative antihistamine up-titration in patients with chronic urticaria who did not respond to standard therapy.
Date of disclosure of the study information 2012/06/01
Last modified on 2014/04/22 16:49:11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A study evaluating efficacy of non-sedative antihistamine up-titration in patients with chronic urticaria who did not respond to standard therapy.

Acronym

UPDATE trial:Up-dosing antihistamine trial

Scientific Title

A study evaluating efficacy of non-sedative antihistamine up-titration in patients with chronic urticaria who did not respond to standard therapy.

Scientific Title:Acronym

UPDATE trial:Up-dosing antihistamine trial

Region

Japan


Condition

Condition

chronic urticaria

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of up-titration vs. fixed doses of antihistamine on clinical response, safety and QOL in patients with chronic urticaria that do not respond well to usual doses of antihistamines, using bepotastine besilate as one of the clinically widely used antihistamines.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

- Improvement in the degree of itching in the daytime and nighttime

Key secondary outcomes

- Improvement in the duration of rash
- Improvement in the degree of skin eruption (erythema, wheal, area/ extent)
- Change in QOL (Skindex-16)
- Overall improvement rating (degree of skin eruption, degree of itching)
- Degree of satisfaction regarding efficacy
- Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

14 days-treatment with bepotastine besilate(20mg x twice/day)

Interventions/Control_2

14 days-treatment with bepotastine besilate(10mg x twice/day)

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who have been diagnosed with chronic urticaria.
2) Patients having urticaria with a severity level of 3 or higher according to "Guidelines for the Diagnosis and Treatment of Urticaria and Angioedema" after treatment with oral bepotastine besilate for 2 weeks.
3) Patients who received an explanation of the study detail and signed a written consent form.
4) Patients aged 16 years or older at the time of registration. For those under 20 years, their guardians must also have signed the consent form.

Key exclusion criteria

1) Patients with a known allergy to any component of the study drug.
2) Pregnant or possibly pregnant women, or breastfeeding women. Women who wish to become pregnant during study participation.
3) Patients who are judged inappropriate to participate in the study by the investigator.

Target sample size

200


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 2-4-1, Hamamatsu-cho, Minato-ku, Tokyo 105-6124 Japan

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

2012 Year 06 Month 01 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 04 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 06 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



Management information

Registered date

2012 Year 05 Month 31 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=R000009499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name