UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036018
Receipt number 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 12:16:23

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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 or person

Institute

Nagasaki university

Institute

Department

Personal name



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

Value
https://center6.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