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Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00421109
First received: January 9, 2007
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

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

Enrollment: 522
Study Start Date: July 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bilastine 20 mg
 Drug: Bilastine
Encapsulated 20 mg Tablet. Once daily for 28 days
Active Comparator: 2
Levocetirizine 5 mg
 Drug: Levocetirizine
Encapsulated 5 mg tablet. Once daily for 28 days
Other Name: Xyzall
Placebo Comparator: 3
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

Publications:

Responsible Party: Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT00421109     History of Changes
Other Study ID Numbers: BILA 2006/UCI, 2006-001245-33
Study First Received: January 9, 2007
Last Updated: April 4, 2012
Health Authority: Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
Cetirizine
Histamine H1 Antagonists, Non-Sedating
 Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013