Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

April 4, 2012 updated by: Faes Farma, S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

522

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1035
        • Centre nº 101
      • Buenos Aires, Argentina, 1280
        • Centre nº 105
      • Buenos Aires, Argentina, 1406
        • Centre nº 104
      • Buenos Aires, Argentina, 1425
        • Centre nº 103
      • Buenos Aires, Argentina, 1425
        • Centre nº 107
      • Buenos Aires, Argentina, 1425
        • Centre nº 109
      • Buenos Aires, Argentina, 6500
        • Centre nº 108
      • Mar Del Plata / Buenos Aires, Argentina, 7600
        • Centre nº 100
      • Rosario - Santa Fe, Argentina, 2000
        • Centre nº 106
      • Salta, Argentina, 4400
        • Centre nº 102
  • Belgium
      • Aalst, Belgium, 3300
        • Centre nº 202
      • Edegem, Belgium, 2650
        • Centre nº 200
      • Gent, Belgium, 3000
        • Centre nº 201
      • Gent, Belgium, 3000
        • Centre nº 204
      • Kortrijk, Belgium, 8500
        • Centre nº 203
  • France
      • Lyon, France, 69003
        • Centre nº 302
      • Marseille cedex 9, France, 13274
        • Centre nº 305
      • Nice cedex 3, France, 06202
        • Centre nº 307
      • Paris cedex 10, France, 75475
        • Centre nº 303
      • Quimper, France, 29000
        • Centre nº 308
      • Reims, France, 51092
        • Centre nº 301
  • Germany
      • Berlin, Germany, 12353
        • Centre nº 411
      • Berlin, Germany, 13055
        • Centre nº 404
      • Berlin, Germany, 13439
        • Centre nº 410
      • Hamburg, Germany, 20354
        • Centre nº 400
      • Hannover, Germany, 30159
        • Centre nº 407
      • Leipzig, Germany, 4103
        • Centre nº 406
  • Poland
      • Iwonicz Zdroj, Poland, 38-440
        • Centre nº 505
      • Krakow, Poland, 31-462
        • Centre nº 507
      • Krakow, Poland, 31-908
        • Centre nº 503
      • Lodz, Poland, 91-347
        • Centre nº 504
      • Lublin, Poland, 20-080
        • Centre nº 502
      • Poznan, Poland, 60-631
        • Centre nº 506
      • Warszawa, Poland, 00-891
        • Centre nº 501
      • Wroclaw, Poland, 50-044
        • Centre nº 500
  • Romania
      • Brasov, Romania, 500414
        • Centre nº 704
      • Bucharest, Romania, 040213
        • 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
      • Craiova Dolj, Romania
        • Centre nº 703
  • Spain
      • Barcelona, Spain, 08036
        • Centre nº 805
      • Madrid, Spain, 28004
        • Centre nº 800
      • Valencia, Spain, 46009
        • Centre nº 806
    • Alava
      • Vitoria, Alava, Spain, 01004
        • Centre nº 804
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Centre nº 802
    • Madrid
      • Leganes, Madrid, Spain, 28911
        • Centre nº 801
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Centre nº 803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Drug: Placebo
Encapsulated tablet. Once daily for 28 days
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 Names:
  • Xyzall

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Reflective and Instantaneous symptoms scores.
Time Frame: 28 days
28 days
QoL questionnaire.
Time Frame: 28 days
28 days
Overall assessment of discomfort caused by CIU.
Time Frame: 28 days
28 days
Investigator's overall clinical impression.
Time Frame: End of study
End of study
Assessment of the Impact of urticaria on the sleep scale.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BILA 2006/UCI
  • 2006-001245-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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