chronic urticaria chronic urticaria
Conditions
Interventions
Evaluation 1: The first oral administration
A 10mg of the test drug should be administered orally at the first time to be observed the skin eruption (erythema score >= 2 and wheal score >= 2 ) in the
Sponsors
Kitahara Hiroto
Kawashima Makoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who were diagnosed with chronic urticaria. 2) Subjects with the skin eruption (erythema score >= 2 and wheal score >= 2 ). 3) Subjects with the skin eruption in the area where photos can be taken. 4) Subjects who were 20 years old or older, less than 65 years old when registered. 5) Subjects with written consent after having informed of the study contents.
Exclusion criteria
Exclusion criteria: 1) Subjects with hypersensitivity to study drug (correspond to contraindications) . 2) Subjects who were treated with drugs except for the antihistamine (histamine H1 receptor antagonist) for chronic urticaria. 3) Subjects under treatment for allergic rhinitis. 4) Subjects whom the doctor judged as inappropriate for the study. 5) Pregnant or possibly pregnant women, breast feeding women, or women who wish to become pregnant during study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the skin eruption disappearance from the first oral administration of a test drug after observation of the skin eruption (erythema score < 1 and wheal score 0). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time to score 0 of the itch NRS from the first oral administration of the test drug. 2) Change in itch score. 3) Evaluation of the effectiveness of both 10mg once daily for 14 days, and 20mg once daily for 14 days. 4) Change in urticaria severity score. 5) Change in urticaria symptom score (urticaria NRS). 6) Relationship between symptoms (erythema, wheal and itch) and factors that influence on improvement of symptoms. | — |
Contacts
Public ContactYoshitaka Ogaki
EBC&M LLC
Outcome results
None listed