Clinical trial NCT00421109: Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urticaria
Keywords: Urticaria
Hives
Wheals
Flare
Chronic
Idiopathic
Erythema
Skin diseases, vascular
Hypersensitivity, Immediate
Allergic
Cutaneous
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 28 days
Secondary outcomes:
measure: Reflective and Instantaneous symptoms scores.
timeFrame: 28 days
measure: QoL questionnaire.
timeFrame: 28 days
measure: Overall assessment of discomfort caused by CIU.
timeFrame: 28 days
measure: Investigator's overall clinical impression.
timeFrame: End of study
measure: Assessment of the Impact of urticaria on the sleep scale.
timeFrame: 28 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Centre nº 101
city: Buenos Aires
country: Argentina
facility: Centre nº 105
city: Buenos Aires
country: Argentina
facility: Centre nº 104
city: Buenos Aires
country: Argentina
facility: Centre nº 103
city: Buenos Aires
country: Argentina
facility: Centre nº 107
city: Buenos Aires
country: Argentina
facility: Centre nº 109
city: Buenos Aires
country: Argentina
facility: Centre nº 108
city: Mar Del Plata / Buenos Aires
country: Argentina
facility: Centre nº 100
city: Rosario - Santa Fe
country: Argentina
facility: Centre nº 106
city: Salta
country: Argentina
facility: Centre nº 102
city: Aalst
country: Belgium
facility: Centre nº 202
city: Edegem
country: Belgium
facility: Centre nº 200
city: Gent
country: Belgium
facility: Centre nº 201
city: Gent
country: Belgium
facility: Centre nº 204
city: Kortrijk
country: Belgium
facility: Centre nº 203
city: Lyon
country: France
facility: Centre nº 302
city: Marseille cedex 9
country: France
facility: Centre nº 305
city: Nice cedex 3
country: France
facility: Centre nº 307
city: Paris cedex 10
country: France
facility: Centre nº 303
city: Quimper
country: France
facility: Centre nº 308
city: Reims
country: France
facility: Centre nº 301
city: Berlin
country: Germany
facility: Centre nº 411
city: Berlin
country: Germany
facility: Centre nº 404
city: Berlin
country: Germany
facility: Centre nº 410
city: Hamburg
country: Germany
facility: Centre nº 400
city: Hannover
country: Germany
facility: Centre nº 407
city: Leipzig
country: Germany
facility: Centre nº 406
city: Iwonicz Zdroj
country: Poland
facility: Centre nº 505
city: Krakow
country: Poland
facility: Centre nº 507
city: Krakow
country: Poland
facility: Centre nº 503
city: Lodz
country: Poland
facility: Centre nº 504
city: Lublin
country: Poland
facility: Centre nº 502
city: Poznan
country: Poland
facility: Centre nº 506
city: Warszawa
country: Poland
facility: Centre nº 501
city: Wroclaw
country: Poland
facility: Centre nº 500
city: Brasov
country: Romania
facility: Centre nº 704
city: Bucharest
country: Romania
facility: Centre nº 700
city: Bucharest
country: Romania
facility: Centre nº 701
city: Bucharest
country: Romania
facility: Centre nº 702
city: Bucharest
country: Romania
facility: Centre nº 705
city: Bucharest
country: Romania
facility: Centre nº 706
city: Bucharest
country: Romania
facility: Centre nº 707
city: Craiova Dolj
country: Romania
facility: Centre nº 703
city: Vitoria
country: Spain
facility: Centre nº 804
state: Alava
city: Badalona
country: Spain
facility: Centre nº 802
state: Barcelona
city: Leganes
country: Spain
facility: Centre nº 801
state: Madrid
city: Bilbao
country: Spain
facility: Centre nº 803
state: Vizcaya
city: Barcelona
country: Spain
facility: Centre nº 805
city: Madrid
country: Spain
facility: Centre nº 800
city: Valencia
country: Spain
facility: Centre nº 806
Study officials:
affiliation: HOSP CLINICO SAN CARLOS, SERVICIO DERMATOLOGIA (Madrid- Spain)
name: OLMOS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ GENT/ DE PINTELAAN 185 (Belgium)
name: DE WEERT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL ST LOUIS/SCE DERMATOLOGIE/1 AV. CLAUDE VELLEFAUX (Paris- France)
name: DUBERTRET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIV. KLINIKUM LEIPZIG/KLINIK FÜR DERMATOLOGIE (Germany)
name: SIMON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SZPITAL SPECJALISTYCZNY IM.S. ZEROMSKIEGO/ODDZIAL DERMATOLOGII/ OS. MLODOSCI 11 (Krakow- Poland)
name: KAPINSKA-MROWIECKA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spit Clin Dermato-Venero."Prof.Dr./Scarlat Longhin"/Calea Serban Voda216,sector4 (Bucharest- Romania)
name: BENEA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CONSULTORIO DE ALERGIA 1° PISO/HOSPITAL JUAN A. FERNANDEZ/CERVINO 3355 (Buenos Aires- Argentina)
name: HERRERO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.