UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003445 |
|---|---|
| Receipt number | R000003100 |
| Scientific Title | The study on the effectiveness of protease inhibitors for patients with refractory urticaria |
| Date of disclosure of the study information | 2010/04/05 |
| Last modified on | 2018/04/04 19:18:38 |
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Basic information
Public title
The study on the effectiveness of protease inhibitors for patients with refractory urticaria
Acronym
The effectiveness of protease inhibitors for patients with urticaria
Scientific Title
The study on the effectiveness of protease inhibitors for patients with refractory urticaria
Scientific Title:Acronym
The effectiveness of protease inhibitors for patients with urticaria
Region
| Japan |
Condition
Condition
urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of protease inhibitors for patients with refractory urticaria, we evaluate the urticarial symptoms with the administration of protease inhibitors, nafamostat mesilate and camostat mesilate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Urticarial symptom scores before and after medications
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
The intravenous administration of nafamostat mesilate (0.04 mg/kg/hr), followed by the oral administartion of camostat mesilate (600 mg/day)
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 urticaria
1. Not less than 20 years old (no upper limit)
2. Whose quality of life (QOL) were severely impaired from insufficient efficacy of conventional treatments or their adverse effects
3. Written informed consent
4. Who can be hospitalized for the treatment and attend the hospital after discharge for a month
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. Patients who were administered nafamostat mesilate and camostat mesilate with serious adverse events.
5. Patients in contraindication of nafamostat mesilate and camostat mesilate.
6. Others who the physician judges are not suitable as subjects
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michihiro Hide |
Organization
Hiroshima University
Division name
Department of Dermatology, Programs for Biomedical Research, Division of Molecular Medical Science, Graduate School of Biomedical Sciences
Zip code
Address
1-2-3 Kasumi Minami-ku Hiroshima 734-8551
TEL
082-257-5237
takumuchi0116@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimi Matsuo |
Organization
Hiroshima University
Division name
Department of Dermatology
Zip code
Address
1-2-3 Kasumim, Minami-ku, Hiroshima
TEL
082-257-5237
Homepage URL
ymatsuo@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Programs for Biomedical Research, Division of Molecular Medical Science, Graduate School of Biomedical 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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | 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 | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | 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
Management information
Registered date
| 2010 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003100
