chronic urticaria
Conditions
Interventions
14 days-treatment with bepotastine besilate(20mg x twice/day)
14 days-treatment with bepotastine besilate(10mg x twice/day)
Sponsors
Non-Profit Organization Health Institute Research of Skin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been diagnosed with chronic urticaria. 2) Patients having urticaria with a severity level of 3 or higher according to "Guidelines for the Diagnosis and Treatment of Urticaria and Angioedema" after treatment with oral bepotastine besilate for 2 weeks. 3) Patients who received an explanation of the study detail and signed a written consent form. 4) Patients aged 16 years or older at the time of registration. For those under 20 years, their guardians must also have signed the consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with a known allergy to any component of the study drug. 2) Pregnant or possibly pregnant women, or breastfeeding women. Women who wish to become pregnant during study participation. 3) Patients who are judged inappropriate to participate in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Improvement in the degree of itching in the daytime and nighttime | — |
Secondary
| Measure | Time frame |
|---|---|
| - Improvement in the duration of rash - Improvement in the degree of skin eruption (erythema, wheal, area/ extent) - Change in QOL (Skindex-16) - Overall improvement rating (degree of skin eruption, degree of itching) - Degree of satisfaction regarding efficacy - Safety | — |
Countries
Japan
Outcome results
None listed