UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032661
Receipt number R000037243
Scientific Title The effect of desloratadine on the urticariaresponse to the thermal stimuli.
Date of disclosure of the study information 2018/05/21
Last modified on 2018/05/21 15:12:09

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Basic information

Public title

The effect of desloratadine on the urticariaresponse to the thermal stimuli.

Acronym

The effect of desloratadine on the urticariaresponse to the thermal stimuli.

Scientific Title

The effect of desloratadine on the urticariaresponse to the thermal stimuli.

Scientific Title:Acronym

The effect of desloratadine on the urticariaresponse to the thermal stimuli.

Region

Japan


Condition

Condition

urticaria

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficacy of desloratadine on the urticaria response to the thermal stimuli

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The change in the critical temperature thresholds from baseline to week 8 of the treatment period

Key secondary outcomes

The change in UAS


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Desloratadine for 8 weeks

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

12 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Age: 12-79 yrs
2)Positive results for Temp Test

Key exclusion criteria

1) Systemic treatment with corticosteroid and/or immunosuppressants
2) Liver and/or renal dysfunction(AST/ALT>100IU/ml, serum creatinine>1.5 mg/dl)
3) Pregnancy and brestfeeding

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoko Inomata

Organization

Yokohama City University

Division name

Dermatology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2675

Email

ninomata@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Amiko Hakuta

Organization

Yokohama City University

Division name

Dermatology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2675

Homepage URL


Email

ninomata@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University

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

2018 Year 05 Month 21 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

Preinitiation

Date of protocol fixation

2018 Year 04 Month 09 Day

Date of IRB


Anticipated trial start date

2018 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

2018 Year 05 Month 21 Day

Last modified on

2018 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037243


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name