UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003326 |
|---|---|
| Receipt number | 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 16:30:14 |
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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
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
Sponsor or person
Institute
Department of Dermatology Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004040
