UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006953 |
|---|---|
| Receipt number | R000008211 |
| Scientific Title | Retrospective examination about implication of platelet activation in pathogenesis of chronic urticaria |
| Date of disclosure of the study information | 2011/12/26 |
| Last modified on | 2011/12/26 18:30:18 |
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Basic information
Public title
Retrospective examination about implication of platelet activation in pathogenesis of chronic urticaria
Acronym
Retrospective examination for chronic urticaria
Scientific Title
Retrospective examination about implication of platelet activation in pathogenesis of chronic urticaria
Scientific Title:Acronym
Retrospective examination for chronic urticaria
Region
| Japan |
Condition
Condition
chronic urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although chronic urticaria is common disease in daily practice and sometimes impairs patient's QoL and life, there has been no consensus treatment method for intractable urticaria. Recently, abnormality of hemostasis has been thought to involve in pathogenesis of intractable chronic urticaria. This study focused on the coagulation system, and accumulate the information of intractable chronic uriticaria retrospectively.
Basic objectives2
Others
Basic objectives -Others
explore the pathogenesis of intractable chronic urticaria
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a) symptom diary
b) QoL (Skindex-16)
c) visual analogue scale to evaluate the intensity of itch
Key secondary outcomes
Base
Study type
Observational
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
| 12 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with agreement and fulfilled with diagnostic criteria of Japanese Dermatological Association were enrolled.
Key exclusion criteria
patients without agreement
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Katayama |
Organization
Osaka University
Division name
Dermatology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Murota |
Organization
Osaka university
Division name
Dermatology
Zip code
Address
TEL
06-6879-3031
Homepage URL
Sponsor or person
Institute
Dept of dermatology, Osaka university
Institute
Department
Personal name
Funding Source
Organization
Dept of Dermatology, Osaka 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
| 2011 | Year | 12 | Month | 26 | 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
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Confidentiality of personal information was protected. From the accumulated data, the causes of refractory nature are now considering.
Management information
Registered date
| 2011 | Year | 12 | Month | 26 | Day |
Last modified on
| 2011 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008211
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
