UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010020 |
|---|---|
| Receipt number | R000010724 |
| Scientific Title | Clinical study to investigate the efficacy of warfarin for intractable urticaria |
| Date of disclosure of the study information | 2013/02/18 |
| Last modified on | 2017/08/17 15:05:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical study to investigate the efficacy of warfarin for intractable urticaria
Acronym
Clinical study to investigate the efficacy of warfarin for intractable urticaria
Scientific Title
Clinical study to investigate the efficacy of warfarin for intractable urticaria
Scientific Title:Acronym
Clinical study to investigate the efficacy of warfarin for intractable urticaria
Region
| Japan |
Condition
Condition
Urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy, safety, and doses of warfarin for intractable urticaria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms and Urticarial scores before and after taking warfarin
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Warfarin
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A) Patients who are suffuring from urticaria and are 20 years old or more and less than 70 years old.
B) Patients who are insufficiently controlled by standard therapies, or are not able to use standard medicines due to the adverse effects.
C) Patients who can come to our outpatient clinic.
D) Patients who can give consent in writing.
Key exclusion criteria
A) Patiets who take medical agents that influence on coagulation system.
B) Bleeding patients.
C) Patients who has the risks of bleeding.
E) Patients who are recently operated or injured.
F) Patients who previously had the adverse drug reaction against warfarin. And patients who can not stop taking medications which show drug interaction with warfarin.
G) Patients who are pregnant or have chance of pregnancy.
H) Patients who are medicated by vitamineK.
I) Patiens who are pegged as unsuitable for this study by their doctor.
J) Patients who has the potential of injury or contused wound by heavy exercise or work.
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, Integrated Health Sciences, Institute of Biomedical & Health Sciences, Hiroshima University
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 18 | 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
| 2013 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 12 | Day |
Last modified on
| 2017 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010724
