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
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
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
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
