Unique ID issued by UMIN | UMIN000006028 |
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Receipt number | R000007135 |
Scientific Title | A Study on the action mechanism of Ebastine for chronic urticaria and efficacy and safety in the long term follow-up trial |
Date of disclosure of the study information | 2011/09/01 |
Last modified on | 2011/07/23 10:10:30 |
A Study on the action mechanism of Ebastine for chronic urticaria and efficacy and safety in the long term follow-up trial
Trial of Ebastine for chronic urticaria
A Study on the action mechanism of Ebastine for chronic urticaria and efficacy and safety in the long term follow-up trial
Trial of Ebastine for chronic urticaria
Japan |
Chronic urticaria
Dermatology |
Others
NO
To study the mechanism in effective action through observing chronological changes in a long term follow up trial of ebastine for chronic urticaria and evaluating them clinically and pharmacologically. Subsequently, to study efficacy and safety of Ebastine
Others
To study mechanism in effective action, and efficacy and safety
Confirmatory
Pragmatic
Not applicable
1) Quantification of Histamine H1 receptor mRNA
2) Enhancement of skin conditions
3) With or without relapse
4) Improvement of Patients QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
8 week-treatment with ebastine(10mg/day)
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients diagnosed as chronic urticaria
1) patients of the level 3 patients or higher defined by Guidelines for the Diagnosis and Treatment of Urticaria and Angioedema
2) Patients who gave their written informed consent
1) Patients complicated with a skin disorder blocking response evaluation
2) Patients who do not avoid continual use of drugs interrupting response evaluation (antiallergics, oral steroids, immunosuppressives) , except for patients who do not have a plan to change the of the drug dosage during the trial
3) Patients with severe complications including hepatic disease, renal disease, cardiac disease
4) Patients with pregnancy, its chance, and lactation
5) Patients receiving hyposensitization therapy
6) Patients taking antihistamines during 4 weeks before starting the trial
7) Patients whom doctors regarded inappropriate for the trial
20
1st name | |
Middle name | |
Last name | Akira Kawada |
Kinki University
Department of Dermatology
377-2 oonohigasi oosakasayama 589-8511
072-366-0221
1st name | |
Middle name | |
Last name |
Kinki University
Department of Dermatology
072-366-0221
Department of Dermatology,Kinki University
Dainippon Sumitomo Pharma Co.,Ltd.
Profit organization
NO
2011 | Year | 09 | Month | 01 | Day |
Unpublished
Preinitiation
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2011 | Year | 07 | Month | 23 | Day |
2011 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007135
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