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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010519
Receipt No. R000012289
Scientific Title Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.
Date of disclosure of the study information 2013/04/17
Last modified on 2018/03/29

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Basic information
Public title Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.
Acronym Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.
Scientific Title Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.
Scientific Title:Acronym Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)To measure, collect, and analyze the data of scratching ratio from atopic dermatitis patients by wearing a scratching sound measuring instrument developed at Mie University.
2)Compare the scratching ratio and dermatitis severity.
3)To measure brain waves using electroencephalograph from the subjects obtained the informed consent.
4)Analyze the relation between scratch ratio and electroencephalograph (grade of deep sleep and sleep arousal).
5)The analysis of the effect of antihistamine medication for the prevention of the scratching and quality of sleep.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of the scratching ratio and depth of the sleep.
The measurement will be performed on the day -2, -1 and 7 for atopic dermatitis patients.
The measurement on day 7 day can be extended up to other 3 days, in case the subject is not available on day7.
The VAS value of itch and the dermatitis score (EASI,ELQI) are measured for atopic dermatitis patient.
Medication and the measurement on day 7 will not be performed for the healthy individuals.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In addition to the usual treatment(topical medicine), use the tested product.
Interventions/Control_2 In addition to the usual treatment(topical medicine), use the placebo.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Persons with severe or moderate disease severity classification defined by atopic dermatitis Japanese Dermatological Association.
2)18 years of age or older (at the time of obtaining informed consent)
3)Unquestioned gender.
4)Outpatient
5)Persons with voluntary documented consent form.
6)Who with night itching.
Key exclusion criteria 1)Those who may be pregnant or possible pregnant.
2)Those who have critical renal dysfunction and an impaired liver function.
3)The person under the specific or nonspecific de-sensitization treatment.
4)Those who took or injected a steroid, methotrexate, and cyclosporin in two weeks of the test .
5)Those who took the antihistamine within one week before the trial.
6)Those who have been engaged in business, such as operation of the car or machine.
7)The patient who is under the treatment of PUVA therapy using photo-senstive pills.
8)The patient with hypersensitivity or a drug-induced organ injury in the past with the use of Olopatadine, such as a Olopatadine hydrochloride (areroc(R)) and eye-drops Patanol (R).
9)Have lactose intolerance.
10)The person who is unsuitable for the entry judged by a doctor.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Yamanaka, M.D.,Ph.D.
Organization Mie University, Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Mie University, Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address
TEL 059-231-5422
Homepage URL
Email

Sponsor
Institute Mie University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyowa Hakko Kirin Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
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 問診:三重大学医学部附属病院(三重県) 睡眠時測定:津都ホテル(三重県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 17 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
2013 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 18 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
2013 Year 04 Month 17 Day
Last modified on
2018 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012289

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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