Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Urticaria

Intervention / Treatment
-----------------
* Drug: Bilastine
* Drug: Levocetirizine
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bilastine 20 mg | Drug: Bilastine<br>* Encapsulated 20 mg Tablet. Once daily for 28 days<br>|
| Active Comparator: 2<br>Levocetirizine 5 mg | Drug: Levocetirizine<br>* Encapsulated 5 mg tablet. Once daily for 28 days<br>* Other names: Xyzall;|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Encapsulated tablet. Once daily for 28 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline, in the am/pm Total Symptom Score (TSS3), over the 28 days of the treatment period according to the patient's assessment in the diary card. (Reflective Symptoms) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflective and Instantaneous symptoms scores. |  | 28 days | 
| QoL questionnaire. |  | 28 days | 
| Overall assessment of discomfort caused by CIU. |  | 28 days | 
| Investigator's overall clinical impression. |  | End of study | 
| Assessment of the Impact of urticaria on the sleep scale. |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urticaria, Hives, Wheals, Flare, Chronic, Idiopathic, Erythema, Skin diseases, vascular, Hypersensitivity, Immediate, Allergic, Cutaneous