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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003326
Receipt No. R000004040
Scientific Title A clinical trial to determine the effect of olopatadine on itching in hand eczema
Date of disclosure of the study information 2010/03/23
Last modified on 2010/03/30

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Basic information
Public title A clinical trial to determine the effect of olopatadine on itching in hand eczema
Acronym A clinical trial to determine the effect of olopatadine on itching in hand eczema
Scientific Title A clinical trial to determine the effect of olopatadine on itching in hand eczema
Scientific Title:Acronym A clinical trial to determine the effect of olopatadine on itching in hand eczema
Region
Japan

Condition
Condition Hand eczema
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 TAn examination of the effect of an antihistamine drug on itch in hand rash patient he examination of the effect of the antihistamine for the itch of the hand rash patient
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Visual analogue scale)
Key secondary outcomes skin index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olopatadine treated group
Interventions/Control_2 Olopatadine non-treated group
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 outpatients
Patients of hand eczema with itch
Patients provided their own written informed consent for taking part in the study
Key exclusion criteria Subjects treated with oral or injectable steroids
Subjects under specific or inspecific modulation therapy
Subjects suffering from severe hepatic or renal disorders.
Pregnant or lactating women and women who may be pregnant
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koaru Takayama
Organization Tokyo medical and dental university
Division name Dermatology
Zip code
Address Bukyou-ku 1-5-45
TEL 0358035286
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Takayama
Organization Tokyo medical and dental university
Division name Dermatology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Dermatology Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization none
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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 23 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 Open public recruiting
Date of protocol fixation
2010 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 06 Month 01 Day
Date analysis concluded
2011 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 12 Day
Last modified on
2010 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004040

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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