Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria - Full Text View

Sponsored by:	Faes Farma, S.A.
Information provided by:	Faes Farma, S.A.
ClinicalTrials.gov Identifier:	NCT00421109

Purpose

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.

Condition	Intervention	Phase
Urticaria	Drug: Bilastine Drug: Levocetirizine Drug: Placebo	Phase III

MedlinePlus related topics: Allergy Hives Skin Conditions

Drug Information available for: Levocetirizine dihydrochloride Levocetirizine Bilastine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Faes Farma, S.A.:

Primary Outcome Measures:

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) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reflective and Instantaneous symptoms scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
QoL questionnaire. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Overall assessment of discomfort caused by CIU. [ Designated as safety issue: No ]
Investigator's overall clinical impression. [ Time Frame: End of study ] [ Designated as safety issue: No ]
Assessment of the Impact of urticaria on the sleep scale. [ Designated as safety issue: No ]

Enrollment:	522
Study Start Date:	July 2006
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental Bilastine 20 mg	Drug: Bilastine Encapsulated 20 mg Tablet. Once daily for 28 days
2: Active Comparator Levocetirizine 5 mg	Drug: Levocetirizine Encapsulated 5 mg tablet. Once daily for 28 days
3: Placebo Comparator Placebo	Drug: Placebo Encapsulated tablet. Once daily for 28 days

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421109

Show 50 Study Locations

Sponsors and Collaborators

Faes Farma, S.A.

Investigators

Principal Investigator:	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)

More Information

Responsible Party:	Faes Farma, S.A ( Dr. Ander Sologuren )
Study ID Numbers:	BILA 2006/UCI, Eudra CT Nº: 2006-001245-33
Study First Received:	January 9, 2007
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00421109
Health Authority:	Spain: Spanish Agency of Medicines; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Romania: National Medicines Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Poland: Ministry of Health

Keywords provided by Faes Farma, S.A.:

Urticaria
Hives
Wheals
Flare
Chronic
Idiopathic

Erythema
Skin diseases, vascular
Hypersensitivity, Immediate
Allergic
Cutaneous

Study placed in the following topic categories:

Hypersensitivity
Erythema
Skin Diseases
Levocetirizine

Hypersensitivity, Immediate
Histamine phosphate
Urticaria
Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Skin Diseases, Vascular
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Immune System Diseases

Physiological Effects of Drugs
Histamine Agents
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009