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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036018
Receipt No. R000041030
Scientific Title Analytical research to explore the objective indicator of intensity of itch
Date of disclosure of the study information 2019/02/27
Last modified on 2019/02/27

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Basic information
Public title Analytical research to explore the objective indicator of intensity of itch
Acronym Analytical research to explore the objective indicator of intensity of itch
Scientific Title Analytical research to explore the objective indicator of intensity of itch
Scientific Title:Acronym Analytical research to explore the objective indicator of intensity of itch
Region
Japan

Condition
Condition pruritus
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is an exploratory and analytical observational study aiming at objective evaluation method of itching and searching for biomarkers.
Basic objectives2 Others
Basic objectives -Others subjective/objective evaluation method of itching
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual analogue scale
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
4 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who satisfy all the following criteria will be included.
1. Age: 4 years and over
2. Gender: No prejudice
3. Include both hospitalization / outpatient treatment
4. After receiving sufficient explanation for participation in this study, patients who obtained document consent will be included.
Key exclusion criteria Patients applicable to even one of the following are excluded as subjects
1. Patients with Nicolsky phenomenon
2. Patients who have severe allergy to tapes or self-adhesive covering materials
3. In addition, patients whose research managers judged inappropriate as research subjects
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Murota
Organization Nagasaki university hospital
Division name Dermatology, Allergology
Zip code
Address Nagasaki city, Sakamoto, 1-7-1
TEL 095-819-7200
Email h-murota@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Murota
Organization Nagasaki university hospital
Division name Dermatology, Allergology
Zip code
Address Nagasaki city, Sakamoto, 1-7-1
TEL 095-819-7200
Homepage URL
Email h-murota@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki university
Institute
Department

Funding Source
Organization Nagasaki university
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
2019 Year 02 Month 27 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
2019 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 04 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 1. Calculate the amount of change and rate of change in itching VAS, visit 1 vs. visit 2/3 for outpatients, comparison at hospitalization for hospitalization vs before discharge. The t test of correspondence is carried out for the verification. From the results, the subjects are classified into a group with improved itching and another group.
2. Cross tabulate the background factors related to the differences between the groups and search for items with significant differences in the chi-squared test.
3. Consider the involvement of confounding factors and conduct multiple logistic analysis as a sub-analysis.
4. Analyze the presence or absence of correlation between each evaluation result and evaluate with Pearson correlation coefficient and significance level.

Management information
Registered date
2019 Year 02 Month 26 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041030

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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