Overview

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Faes Farma, S.A.
Treatments:
Cetirizine
Levocetirizine
Criteria
Inclusion Criteria:

- 18 to 70 years old.

- Documented history of CIU for at least 6 weeks prior to entry in the study.

Exclusion Criteria:

- Dermatological pathology other than chronic idiopathic urticaria.

- History of autoimmune disorders, Hodgkin's disease, lymphoma, leukemia and generalized
cancer.

- Pregnant or breast-feeding women.

- Patients who will be operating heavy machinery or need to drive motor vehicles as an
essential part of their profession.

- Patients who have a recent history (within previous 12 months) of drug addiction or
alcohol abuse.

- Patients who are currently participating in or have participated in another clinical
trial within the last 3 months