NCT00421109

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Levocetirizine 5 mg for the Treatment of Chronic Idiopathic Urticaria

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 522 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 540 patients with CIU will be enrolled in this pivotal, randomised, multicentre, international, double-blind, placebo and active-comparator controlled, parallel study . Patients will be selected from both public and private clinical practices. The study population includes males and females between 18 and 70 years of age, suffering from CIU for at least 6 weeks prior to entry in the study with no identifiable cause.

Conditions

• Urticaria

Interventions

Type	Name	Description
DRUG	Bilastine	Encapsulated 20 mg Tablet. Once daily for 28 days
DRUG	Levocetirizine	Encapsulated 5 mg tablet. Once daily for 28 days
DRUG	Placebo	Encapsulated tablet. Once daily for 28 days

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2007-01-11
• Last updated: 2012-04-05

Locations

50 sites across 7 countries: Argentina, Belgium, France, Germany, Poland, Romania, Spain