UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on the effectiveness of protease inhibitors for patients with refractory urticaria
Title of the study (Brief title)	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	Michihiro Hide
Organization	Hiroshima University
Division name	Department of Dermatology, Programs for Biomedical Research, Division of Molecular Medical Science, Graduate School of Biomedical Sciences
Address	1-2-3 Kasumi Minami-ku Hiroshima 734-8551
TEL	082-257-5237
Email	takumuchi0116@yahoo.co.jp

Public contact
Name of contact person	Yoshimi Matsuo
Organization	Hiroshima University
Division name	Department of Dermatology
Address	1-2-3 Kasumim, Minami-ku, Hiroshima
TEL	082-257-5237
Homepage URL
Email	ymatsuo@hiroshima-u.ac.jp

Sponsor
Institute	Department of Dermatology, Programs for Biomedical Research, Division of Molecular Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003100