Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

NCT00421109 | Completed Phase 3

• 2 other identifiers: BILA 2006/UCI2006-001245-33
• Study Type: interventional
• Target: 522
• Locations: 7 countries
• Sites: 50

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.

Conditions

Urticaria

Keywords

Urticaria; Hives; Wheals; Flare; Chronic; Idiopathic; Erythema; Skin diseases, vascular; Hypersensitivity, Immediate; Allergic; Cutaneous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (3)

1

EXPERIMENTAL

Bilastine 20 mg

Drug: Bilastine

2

ACTIVE COMPARATOR

Levocetirizine 5 mg

Drug: Levocetirizine

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Bilastine DRUG

Encapsulated 20 mg Tablet. Once daily for 28 days

1

Levocetirizine DRUG

Encapsulated 5 mg tablet. Once daily for 28 days

Also known as: Xyzall

2

Placebo DRUG

Encapsulated tablet. Once daily for 28 days

3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years old.
• Documented history of CIU for at least 6 weeks prior to entry in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Faes Farma, S.A.: lead

Study Sites (50)

Centre nº 101

Buenos Aires, 1035, Argentina

Location

Centre nº 105

Buenos Aires, 1280, Argentina

Location

Centre nº 104

Buenos Aires, 1406, Argentina

Location

Centre nº 103

Buenos Aires, 1425, Argentina

Location

Centre nº 107

Buenos Aires, 1425, Argentina

Location

Centre nº 109

Buenos Aires, 1425, Argentina

Location

Centre nº 108

Buenos Aires, 6500, Argentina

Location

Centre nº 100

Mar Del Plata / Buenos Aires, 7600, Argentina

Location

Centre nº 106

Rosario - Santa Fe, 2000, Argentina

Location

Centre nº 102

Salta, 4400, Argentina

Location

Centre nº 202

Aalst, 3300, Belgium

Location

Centre nº 200

Edegem, 2650, Belgium

Location

Centre nº 201

Ghent, 3000, Belgium

Location

Centre nº 204

Ghent, 3000, Belgium

Location

Centre nº 203

Kortrijk, 8500, Belgium

Location

Centre nº 302

Lyon, 69003, France

Location

Centre nº 305

Marseille, 13274, France

Location

Centre nº 307

Nice, 06202, France

Location

Centre nº 303

Paris, 75475, France

Location

Centre nº 308

Quimper, 29000, France

Location

Centre nº 301

Reims, 51092, France

Location

Centre nº 411

Berlin, 12353, Germany

Location

Centre nº 404

Berlin, 13055, Germany

Location

Centre nº 410

Berlin, 13439, Germany

Location

Centre nº 400

Hamburg, 20354, Germany

Location

Centre nº 407

Hanover, 30159, Germany

Location

Centre nº 406

Leipzig, 4103, Germany

Location

Centre nº 505

Iwonicz-Zdrój, 38-440, Poland

Location

Centre nº 507

Krakow, 31-462, Poland

Location

Centre nº 503

Krakow, 31-908, Poland

Location

Centre nº 504

Lodz, 91-347, Poland

Location

Centre nº 502

Lublin, 20-080, Poland

Location

Centre nº 506

Poznan, 60-631, Poland

Location

Centre nº 501

Warsaw, 00-891, Poland

Location

Centre nº 500

Wroclaw, 50-044, Poland

Location

Centre nº 704

Brasov, 500414, Romania

Location

Centre nº 700

Bucharest, 040213, Romania

Location

Centre nº 701

Bucharest, Romania

Location

Centre nº 702

Bucharest, Romania

Location

Centre nº 705

Bucharest, Romania

Location

Centre nº 706

Bucharest, Romania

Location

Centre nº 707

Bucharest, Romania

Location

Centre nº 703

Craiova Dolj, Romania

Location

Centre nº 804

Vitoria-Gasteiz, Alava, 01004, Spain

Location

Centre nº 802

Badalona, Barcelona, 08916, Spain

Location

Centre nº 801

Leganés, Madrid, 28911, Spain

Location

Centre nº 803

Bilbao, Vizcaya, 48013, Spain

Location

Centre nº 805

Barcelona, 08036, Spain

Location

Centre nº 800

Madrid, 28004, Spain

Location

Centre nº 806

Valencia, 46009, Spain

Location

Related 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.

  PMID: 21831011 BACKGROUND

• 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.

  PMID: 19860762 RESULT

MeSH Terms

Conditions

Urticaria; Bronchiolitis Obliterans Syndrome; Erythema; Skin Diseases, Vascular; Hypersensitivity, Immediate

Interventions

bilastine; levocetirizine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: July 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

ES (7); PL (8); DE (6); RO (8); BE (5); AR (10); FR (6)