Urticaria
Conditions
Keywords
Urticaria, Hives, Wheals, Flare, Chronic, Idiopathic, Erythema, Skin diseases, vascular, Hypersensitivity, Immediate, Allergic, Cutaneous
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.
Interventions
DRUGBilastine
Encapsulated 20 mg Tablet. Once daily for 28 days
DRUGLevocetirizine
Encapsulated 5 mg tablet. Once daily for 28 days
DRUGPlacebo
Encapsulated tablet. Once daily for 28 days
Sponsors
Faes Farma, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Argentina, Belgium, France, Germany, Poland, Romania, Spain
Outcome results
None listed