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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
522
Encapsulated 20 mg Tablet. Once daily for 28 days
Encapsulated 5 mg tablet. Once daily for 28 days
Encapsulated tablet. Once daily for 28 days
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)
Time frame: 28 days
Reflective and Instantaneous symptoms scores.
Time frame: 28 days
QoL questionnaire.
Time frame: 28 days
Overall assessment of discomfort caused by CIU.
Time frame: 28 days
Investigator's overall clinical impression.
Time frame: End of study
Assessment of the Impact of urticaria on the sleep scale.
Time frame: 28 days
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