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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001245-33 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bilastine 20 mg |
|
| 2 | Active Comparator | Levocetirizine 5 mg |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilastine | Drug | Encapsulated 20 mg Tablet. Once daily for 28 days |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reflective and Instantaneous symptoms scores. | 28 days | |
| QoL questionnaire. | 28 days | |
| Overall assessment of discomfort caused by CIU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| OLMOS, MD | HOSP CLINICO SAN CARLOS, SERVICIO DERMATOLOGIA (Madrid- Spain) | Principal Investigator |
| DE WEERT, MD | UZ GENT/ DE PINTELAAN 185 (Belgium) | Principal Investigator |
| DUBERTRET, MD | HOPITAL ST LOUIS/SCE DERMATOLOGIE/1 AV. CLAUDE VELLEFAUX (Paris- France) | Principal Investigator |
| SIMON, MD | UNIV. KLINIKUM LEIPZIG/KLINIK FÜR DERMATOLOGIE (Germany) | Principal Investigator |
| KAPINSKA-MROWIECKA, MD | SZPITAL SPECJALISTYCZNY IM.S. ZEROMSKIEGO/ODDZIAL DERMATOLOGII/ OS. MLODOSCI 11 (Krakow- Poland) | Principal Investigator |
| BENEA, MD | Spit Clin Dermato-Venero."Prof.Dr./Scarlat Longhin"/Calea Serban Voda216,sector4 (Bucharest- Romania) | Principal Investigator |
| HERRERO, MD | CONSULTORIO DE ALERGIA 1° PISO/HOSPITAL JUAN A. FERNANDEZ/CERVINO 3355 (Buenos Aires- Argentina) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre nº 101 | Buenos Aires | 1035 | Argentina | |||
| Centre nº 105 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21831011 | Background | Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11. | |
| 19860762 | Result | Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antepara I, Jauregui I, Valiente R; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy. 2010 Apr;65(4):516-28. doi: 10.1111/j.1398-9995.2009.02217.x. Epub 2009 Oct 23. |
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| Levocetirizine |
| Drug |
Encapsulated 5 mg tablet. Once daily for 28 days |
|
|
| Placebo | Drug | Encapsulated tablet. Once daily for 28 days |
|
| 28 days |
| Investigator's overall clinical impression. | End of study |
| Assessment of the Impact of urticaria on the sleep scale. | 28 days |
| Buenos Aires |
| 1280 |
| Argentina |
| Centre nº 104 | Buenos Aires | 1406 | Argentina |
| Centre nº 103 | Buenos Aires | 1425 | Argentina |
| Centre nº 107 | Buenos Aires | 1425 | Argentina |
| Centre nº 109 | Buenos Aires | 1425 | Argentina |
| Centre nº 108 | Buenos Aires | 6500 | Argentina |
| Centre nº 100 | Mar Del Plata / Buenos Aires | 7600 | Argentina |
| Centre nº 106 | Rosario - Santa Fe | 2000 | Argentina |
| Centre nº 102 | Salta | 4400 | Argentina |
| Centre nº 202 | Aalst | 3300 | Belgium |
| Centre nº 200 | Edegem | 2650 | Belgium |
| Centre nº 201 | Ghent | 3000 | Belgium |
| Centre nº 204 | Ghent | 3000 | Belgium |
| Centre nº 203 | Kortrijk | 8500 | Belgium |
| Centre nº 302 | Lyon | 69003 | France |
| Centre nº 305 | Marseille | 13274 | France |
| Centre nº 307 | Nice | 06202 | France |
| Centre nº 303 | Paris | 75475 | France |
| Centre nº 308 | Quimper | 29000 | France |
| Centre nº 301 | Reims | 51092 | France |
| Centre nº 411 | Berlin | 12353 | Germany |
| Centre nº 404 | Berlin | 13055 | Germany |
| Centre nº 410 | Berlin | 13439 | Germany |
| Centre nº 400 | Hamburg | 20354 | Germany |
| Centre nº 407 | Hanover | 30159 | Germany |
| Centre nº 406 | Leipzig | 4103 | Germany |
| Centre nº 505 | Iwonicz-Zdrój | 38-440 | Poland |
| Centre nº 507 | Krakow | 31-462 | Poland |
| Centre nº 503 | Krakow | 31-908 | Poland |
| Centre nº 504 | Lodz | 91-347 | Poland |
| Centre nº 502 | Lublin | 20-080 | Poland |
| Centre nº 506 | Poznan | 60-631 | Poland |
| Centre nº 501 | Warsaw | 00-891 | Poland |
| Centre nº 500 | Wroclaw | 50-044 | Poland |
| Centre nº 704 | Brasov | 500414 | Romania |
| Centre nº 700 | Bucharest | 040213 | Romania |
| Centre nº 701 | Bucharest | Romania |
| Centre nº 702 | Bucharest | Romania |
| Centre nº 705 | Bucharest | Romania |
| Centre nº 706 | Bucharest | Romania |
| Centre nº 707 | Bucharest | Romania |
| Centre nº 703 | Craiova Dolj | Romania |
| Centre nº 804 | Vitoria-Gasteiz | Alava | 01004 | Spain |
| Centre nº 802 | Badalona | Barcelona | 08916 | Spain |
| Centre nº 801 | Leganés | Madrid | 28911 | Spain |
| Centre nº 803 | Bilbao | Vizcaya | 48013 | Spain |
| Centre nº 805 | Barcelona | 08036 | Spain |
| Centre nº 800 | Madrid | 28004 | Spain |
| Centre nº 806 | Valencia | 46009 | Spain |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D004890 | Erythema |
| D017445 | Skin Diseases, Vascular |
| D006969 | Hypersensitivity, Immediate |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C445659 | bilastine |
| C472067 | levocetirizine |
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