UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002585 |
|---|---|
| Receipt number | R000002948 |
| Scientific Title | Analysis of coagulability and coagulation factors before and after the development of symptoms in patients with physical urticaria |
| Date of disclosure of the study information | 2009/10/05 |
| Last modified on | 2018/05/07 18:34:12 |
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Basic information
Public title
Analysis of coagulability and coagulation factors before and after the development of symptoms in patients with physical urticaria
Acronym
Coagulability and coagulation factors before and after the development of urticaria
Scientific Title
Analysis of coagulability and coagulation factors before and after the development of symptoms in patients with physical urticaria
Scientific Title:Acronym
Coagulability and coagulation factors before and after the development of urticaria
Region
| Japan |
Condition
Condition
physical urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the involvement of the coagulation pathway in the pathogenesis of physical urticaria, we investigate coagulability, coagulation factors and levels of blood histamine before and after the development of symptoms in patients with physical urticaria.
Basic objectives2
Others
Basic objectives -Others
Investigation of the pathogenesis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurements regarding coagulability, coagulation factors and levels of blood histamine before and after the development of symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The provocation of urticarial symptoms
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with physical urticaria who
1. are not less than 20 years old (no upper limit)
2. gave written informed consent
Key exclusion criteria
1. Pregnant or lactating women or women of child bearing potential not using contraception
2. Patients with diseases as follows. Liver disease, psychological illness, convulsive and other seizure, heart disease, hemoglobinopathy, hemophilia, uncontrolled diabetes, and autoimmune diseases.
3. Patients who use medications that influence the coagulation and fibrinolytic cascade.
4. Others whom the physician judges are not suitable as subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michihiro Hide |
Organization
Hiroshima University Hospital
Division name
Department of Dermatology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551
TEL
082-257-5237
ed1h-w1de-road@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Morioke |
Organization
Hiroshima University Hospital
Division name
Department of Dermatology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551
TEL
082-257-5237
Homepage URL
morioke-hma@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2009 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 08 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 05 | Day |
Last modified on
| 2018 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002948
