Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

Urticaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421109
• Other study ID #: BILA 2006/UCI
• Secondary ID: 2006-001245-33
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2007
• Last updated: April 4, 2012
• Start date: July 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2012
• Source: Faes Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentRomania: National Medicines AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urticaria

Intervention

Drug:
• Bilastine
Encapsulated 20 mg Tablet. Once daily for 28 days
• Levocetirizine
Encapsulated 5 mg tablet. Once daily for 28 days
• Placebo
Encapsulated tablet. Once daily for 28 days

Locations

Country	Name	City	State
Argentina	Centre nº 101	Buenos Aires
Argentina	Centre nº 103	Buenos Aires
Argentina	Centre nº 104	Buenos Aires
Argentina	Centre nº 105	Buenos Aires
Argentina	Centre nº 107	Buenos Aires
Argentina	Centre nº 108	Buenos Aires
Argentina	Centre nº 109	Buenos Aires
Argentina	Centre nº 100	Mar Del Plata / Buenos Aires
Argentina	Centre nº 106	Rosario - Santa Fe
Argentina	Centre nº 102	Salta
Belgium	Centre nº 202	Aalst
Belgium	Centre nº 200	Edegem
Belgium	Centre nº 201	Gent
Belgium	Centre nº 204	Gent
Belgium	Centre nº 203	Kortrijk
France	Centre nº 302	Lyon
France	Centre nº 305	Marseille cedex 9
France	Centre nº 307	Nice cedex 3
France	Centre nº 303	Paris cedex 10
France	Centre nº 308	Quimper
France	Centre nº 301	Reims
Germany	Centre nº 404	Berlin
Germany	Centre nº 410	Berlin
Germany	Centre nº 411	Berlin
Germany	Centre nº 400	Hamburg
Germany	Centre nº 407	Hannover
Germany	Centre nº 406	Leipzig
Poland	Centre nº 505	Iwonicz Zdroj
Poland	Centre nº 503	Krakow
Poland	Centre nº 507	Krakow
Poland	Centre nº 504	Lodz
Poland	Centre nº 502	Lublin
Poland	Centre nº 506	Poznan
Poland	Centre nº 501	Warszawa
Poland	Centre nº 500	Wroclaw
Romania	Centre nº 704	Brasov
Romania	Centre nº 700	Bucharest
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
Spain	Centre nº 802	Badalona	Barcelona
Spain	Centre nº 805	Barcelona
Spain	Centre nº 803	Bilbao	Vizcaya
Spain	Centre nº 801	Leganes	Madrid
Spain	Centre nº 800	Madrid
Spain	Centre nº 806	Valencia
Spain	Centre nº 804	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Faes Farma, S.A.

Countries where clinical trial is conducted

Argentina,  Belgium,  France,  Germany,  Poland,  Romania,  Spain, 

References & Publications (2)

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. Review. Erratum in: Expert Opin Drug Saf. 2012 Jan;11(1):175. — View Citation

Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antépara I, Jáuregui 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 u — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reflective and Instantaneous symptoms scores.		28 days	No
Secondary	QoL questionnaire.		28 days	No
Secondary	Overall assessment of discomfort caused by CIU.		28 days	No
Secondary	Investigator's overall clinical impression.		End of study	No
Secondary	Assessment of the Impact of urticaria on the sleep scale.		28 days	No