Trial | NCT00421109  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    522
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.
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.
Study Started
Jul 31
2006
Primary Completion
Jul 31
2007
Study Completion
Jul 31
2007
Last Update
Apr 05
2012
Estimate

Drug Bilastine

Encapsulated 20 mg Tablet. Once daily for 28 days

Drug Levocetirizine

Encapsulated 5 mg tablet. Once daily for 28 days

  • Other names: Xyzall

Drug Placebo

Encapsulated tablet. Once daily for 28 days

1 Experimental

Bilastine 20 mg

2 Active Comparator

Levocetirizine 5 mg

3 Placebo Comparator

Placebo

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
No Results Posted