UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003424 |
|---|---|
| Receipt number | R000004146 |
| Scientific Title | A clinical trial to determine the effects of an oral anti-histamine drug on nocturnal scratching behavior in atopic dermatitis patients |
| Date of disclosure of the study information | 2010/04/05 |
| Last modified on | 2014/04/01 12:50:36 |
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Basic information
Public title
A clinical trial to determine the effects of an oral anti-histamine drug on nocturnal scratching behavior in atopic dermatitis patients
Acronym
Nocturnal scratching behavior in atopic dermatitis patients
Scientific Title
A clinical trial to determine the effects of an oral anti-histamine drug on nocturnal scratching behavior in atopic dermatitis patients
Scientific Title:Acronym
Nocturnal scratching behavior in atopic dermatitis patients
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determination of the effects of an anti-histamine drug on nocturnal scratching behavior in atopic dermatitis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A number of times of scratching behavior in night
Key secondary outcomes
Symptom scores
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
An anti-histamine drug and steroid ointment
Interventions/Control_2
Steroid ointment
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Atopic dermatitis patients moderate or severe symptomatic grade according to Japanese Dermatology Association guideline.
Key exclusion criteria
Subjects corresponding to following categories are excluded.
1) Subjects are treated with psychoactive drugs in the past 3 months or applicable to using the drugs.
2) Subjects are not sufficient for the recruitment requirement by drinking alcohol, caffeine or nicotine habitually or dependently
3) Subjects with medical histories of mental disorder or hypersensitivity to drugs.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiko Aihara |
Organization
Yokohama City University hospital
Division name
Department of Dermatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2675
maihara1@med-yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Aihara |
Organization
Yokohama City University hospital
Division name
Department of Dermatology
Zip code
Address
3-9Fukuura, Kanazawa-ku,Yokohama
TEL
045-787-2800
Homepage URL
maihara1@med-yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
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
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
横浜市立大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 05 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 01 | Day |
Last modified on
| 2014 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004146
