Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
NCT ID: NCT00421109
Last Updated: 2012-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
522 participants
INTERVENTIONAL
2006-07-31
2007-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis
NCT00504933
Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension
NCT01127620
A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine
NCT01108783
This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
NCT03926611
Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria
NCT00525382
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Bilastine 20 mg
Bilastine
Encapsulated 20 mg Tablet. Once daily for 28 days
2
Levocetirizine 5 mg
Levocetirizine
Encapsulated 5 mg tablet. Once daily for 28 days
3
Placebo
Placebo
Encapsulated tablet. Once daily for 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented history of CIU for at least 6 weeks prior to entry in the study.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Faes Farma, S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
OLMOS, MD
Role: PRINCIPAL_INVESTIGATOR
HOSP CLINICO SAN CARLOS, SERVICIO DERMATOLOGIA (Madrid- Spain)
DE WEERT, MD
Role: PRINCIPAL_INVESTIGATOR
UZ GENT/ DE PINTELAAN 185 (Belgium)
DUBERTRET, MD
Role: PRINCIPAL_INVESTIGATOR
HOPITAL ST LOUIS/SCE DERMATOLOGIE/1 AV. CLAUDE VELLEFAUX (Paris- France)
SIMON, MD
Role: PRINCIPAL_INVESTIGATOR
UNIV. KLINIKUM LEIPZIG/KLINIK FÜR DERMATOLOGIE (Germany)
KAPINSKA-MROWIECKA, MD
Role: PRINCIPAL_INVESTIGATOR
SZPITAL SPECJALISTYCZNY IM.S. ZEROMSKIEGO/ODDZIAL DERMATOLOGII/ OS. MLODOSCI 11 (Krakow- Poland)
BENEA, MD
Role: PRINCIPAL_INVESTIGATOR
Spit Clin Dermato-Venero."Prof.Dr./Scarlat Longhin"/Calea Serban Voda216,sector4 (Bucharest- Romania)
HERRERO, MD
Role: PRINCIPAL_INVESTIGATOR
CONSULTORIO DE ALERGIA 1° PISO/HOSPITAL JUAN A. FERNANDEZ/CERVINO 3355 (Buenos Aires- Argentina)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre nº 101
Buenos Aires, , Argentina
Centre nº 105
Buenos Aires, , Argentina
Centre nº 104
Buenos Aires, , Argentina
Centre nº 103
Buenos Aires, , Argentina
Centre nº 107
Buenos Aires, , Argentina
Centre nº 109
Buenos Aires, , Argentina
Centre nº 108
Buenos Aires, , Argentina
Centre nº 100
Mar Del Plata / Buenos Aires, , Argentina
Centre nº 106
Rosario - Santa Fe, , Argentina
Centre nº 102
Salta, , Argentina
Centre nº 202
Aalst, , Belgium
Centre nº 200
Edegem, , Belgium
Centre nº 201
Ghent, , Belgium
Centre nº 204
Ghent, , Belgium
Centre nº 203
Kortrijk, , Belgium
Centre nº 302
Lyon, , France
Centre nº 305
Marseille, , France
Centre nº 307
Nice, , France
Centre nº 303
Paris, , France
Centre nº 308
Quimper, , France
Centre nº 301
Reims, , France
Centre nº 411
Berlin, , Germany
Centre nº 404
Berlin, , Germany
Centre nº 410
Berlin, , Germany
Centre nº 400
Hamburg, , Germany
Centre nº 407
Hanover, , Germany
Centre nº 406
Leipzig, , Germany
Centre nº 505
Iwonicz-Zdrój, , Poland
Centre nº 507
Krakow, , Poland
Centre nº 503
Krakow, , Poland
Centre nº 504
Lodz, , Poland
Centre nº 502
Lublin, , Poland
Centre nº 506
Poznan, , Poland
Centre nº 501
Warsaw, , Poland
Centre nº 500
Wroclaw, , Poland
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, , Romania
Centre nº 804
Vitoria-Gasteiz, Alava, Spain
Centre nº 802
Badalona, Barcelona, Spain
Centre nº 801
Leganés, Madrid, Spain
Centre nº 803
Bilbao, Vizcaya, Spain
Centre nº 805
Barcelona, , Spain
Centre nº 800
Madrid, , Spain
Centre nº 806
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-001245-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BILA 2006/UCI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.