NCT02213367

Bilastine Updosing in Chronic Spontaneous Urticaria

Phase 3 Study, Exploratory, Disease Activity Controlled Dose Escalating Study to Assess the Efficacy, and Safety of Treatment With Bilastine 20 mg, 40 mg and 80 mg in Chronic Spontaneous Urticaria.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Urticaria

Interventions

Type	Name	Description
DRUG	Bilastine	20mg (8 weeks)
DRUG	Bilastine	40mg
DRUG	Bilastin	80mg

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-08-11
• Last updated: 2016-08-26

Locations

1 site across 1 country: Germany