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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name