drugset / Trial / NCT02213367

Bilastine Updosing in Chronic Spontaneous Urticaria

NCT02213367

Phase 3 Completed 30 enrolled Charite University, Berlin, Germany
RandomizedParallel-groupOpen-labelTreatment

Summary

Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of the population suffers from the disease. Although all age groups can be affected, the peak incidence is seen between 20 and 40 years of age. The duration of the disease is generally several years but is likely to be longer in more severe cases, cases with concurrent angioedema, in combination with physical urticaria or with a positive autologous serum skin test (autoreactivity). CSU has major detrimental effects on quality of life, with sleep deprivation and psychiatric comorbidity being frequent. It also has a large impact on society in terms of direct and indirect health care costs as well as reduced performance at work and in private life.

Timeline

Start
2014-07
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bilastine Small molecule 20 mg
Comparator Bilastine Small molecule 40 mg
Comparator Bilastine Small molecule 80 mg

Indications