Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
- Registration Number
- NCT00421109
- Lead Sponsor
- Faes Farma, S.A.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 522
- 18 to 70 years old.
- Documented history of CIU for at least 6 weeks prior to entry in the study.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo Placebo 1 Bilastine Bilastine 20 mg 2 Levocetirizine Levocetirizine 5 mg
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (50)
Centre nº 204
🇧🇪Gent, Belgium
Centre nº 107
🇦🇷Buenos Aires, Argentina
Centre nº 507
🇵🇱Krakow, Poland
Centre nº 504
🇵🇱Lodz, Poland
Centre nº 404
🇩🇪Berlin, Germany
Centre nº 410
🇩🇪Berlin, Germany
Centre nº 407
🇩🇪Hannover, Germany
Centre nº 406
🇩🇪Leipzig, Germany
Centre nº 308
🇫🇷Quimper, France
Centre nº 400
🇩🇪Hamburg, Germany
Centre nº 505
🇵🇱Iwonicz Zdroj, Poland
Centre nº 503
🇵🇱Krakow, Poland
Centre nº 502
🇵🇱Lublin, Poland
Centre nº 804
🇪🇸Vitoria, Alava, Spain
Centre nº 805
🇪🇸Barcelona, Spain
Centre nº 803
🇪🇸Bilbao, Vizcaya, Spain
Centre nº 802
🇪🇸Badalona, Barcelona, Spain
Centre nº 800
🇪🇸Madrid, Spain
Centre nº 100
🇦🇷Mar Del Plata / Buenos Aires, Argentina
Centre nº 105
🇦🇷Buenos Aires, Argentina
Centre nº 101
🇦🇷Buenos Aires, Argentina
Centre nº 104
🇦🇷Buenos Aires, Argentina
Centre nº 103
🇦🇷Buenos Aires, Argentina
Centre nº 109
🇦🇷Buenos Aires, Argentina
Centre nº 108
🇦🇷Buenos Aires, Argentina
Centre nº 501
🇵🇱Warszawa, Poland
Centre nº 202
🇧🇪Aalst, Belgium
Centre nº 102
🇦🇷Salta, Argentina
Centre nº 106
🇦🇷Rosario - Santa Fe, Argentina
Centre nº 200
🇧🇪Edegem, Belgium
Centre nº 203
🇧🇪Kortrijk, Belgium
Centre nº 201
🇧🇪Gent, Belgium
Centre nº 302
🇫🇷Lyon, France
Centre nº 500
🇵🇱Wroclaw, Poland
Centre nº 303
🇫🇷Paris cedex 10, France
Centre nº 305
🇫🇷Marseille cedex 9, France
Centre nº 307
🇫🇷Nice cedex 3, France
Centre nº 301
🇫🇷Reims, France
Centre nº 702
🇷🇴Bucharest, Romania
Centre nº 506
🇵🇱Poznan, Poland
Centre nº 704
🇷🇴Brasov, Romania
Centre nº 706
🇷🇴Bucharest, Romania
Centre nº 700
🇷🇴Bucharest, Romania
Centre nº 705
🇷🇴Bucharest, Romania
Centre nº 701
🇷🇴Bucharest, Romania
Centre nº 707
🇷🇴Bucharest, Romania
Centre nº 703
🇷🇴Craiova Dolj, Romania
Centre nº 801
🇪🇸Leganes, Madrid, Spain
Centre nº 806
🇪🇸Valencia, Spain
Centre nº 411
🇩🇪Berlin, Germany