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Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

Primary Purpose

Urticaria

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bilastine
Levocetirizine
Placebo
Sponsored by
Faes Farma, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urticaria focused on measuring Urticaria, Hives, Wheals, Flare, Chronic, Idiopathic, Erythema, Skin diseases, vascular, Hypersensitivity, Immediate, Allergic, Cutaneous

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre nº 101
  • Centre nº 105
  • Centre nº 104
  • Centre nº 103
  • Centre nº 107
  • Centre nº 109
  • Centre nº 108
  • Centre nº 100
  • Centre nº 106
  • Centre nº 102
  • Centre nº 202
  • Centre nº 200
  • Centre nº 201
  • Centre nº 204
  • Centre nº 203
  • Centre nº 302
  • Centre nº 305
  • Centre nº 307
  • Centre nº 303
  • Centre nº 308
  • Centre nº 301
  • Centre nº 411
  • Centre nº 404
  • Centre nº 410
  • Centre nº 400
  • Centre nº 407
  • Centre nº 406
  • Centre nº 505
  • Centre nº 507
  • Centre nº 503
  • Centre nº 504
  • Centre nº 502
  • Centre nº 506
  • Centre nº 501
  • Centre nº 500
  • Centre nº 704
  • Centre nº 700
  • Centre nº 701
  • Centre nº 702
  • Centre nº 705
  • Centre nº 706
  • Centre nº 707
  • Centre nº 703
  • Centre nº 804
  • Centre nº 802
  • Centre nº 801
  • Centre nº 803
  • Centre nº 805
  • Centre nº 800
  • Centre nº 806

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Bilastine 20 mg

Levocetirizine 5 mg

Placebo

Outcomes

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)

Secondary Outcome Measures

Reflective and Instantaneous symptoms scores.
QoL questionnaire.
Overall assessment of discomfort caused by CIU.
Investigator's overall clinical impression.
Assessment of the Impact of urticaria on the sleep scale.

Full Information

First Posted
January 9, 2007
Last Updated
April 4, 2012
Sponsor
Faes Farma, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00421109
Brief Title
Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faes Farma, S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria
Keywords
Urticaria, Hives, Wheals, Flare, Chronic, Idiopathic, Erythema, Skin diseases, vascular, Hypersensitivity, Immediate, Allergic, Cutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
522 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bilastine 20 mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
Levocetirizine 5 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Bilastine
Intervention Description
Encapsulated 20 mg Tablet. Once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Other Intervention Name(s)
Xyzall
Intervention Description
Encapsulated 5 mg tablet. Once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Encapsulated tablet. Once daily for 28 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Reflective and Instantaneous symptoms scores.
Time Frame
28 days
Title
QoL questionnaire.
Time Frame
28 days
Title
Overall assessment of discomfort caused by CIU.
Time Frame
28 days
Title
Investigator's overall clinical impression.
Time Frame
End of study
Title
Assessment of the Impact of urticaria on the sleep scale.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OLMOS, MD
Organizational Affiliation
HOSP CLINICO SAN CARLOS, SERVICIO DERMATOLOGIA (Madrid- Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DE WEERT, MD
Organizational Affiliation
UZ GENT/ DE PINTELAAN 185 (Belgium)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DUBERTRET, MD
Organizational Affiliation
HOPITAL ST LOUIS/SCE DERMATOLOGIE/1 AV. CLAUDE VELLEFAUX (Paris- France)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SIMON, MD
Organizational Affiliation
UNIV. KLINIKUM LEIPZIG/KLINIK FÜR DERMATOLOGIE (Germany)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
KAPINSKA-MROWIECKA, MD
Organizational Affiliation
SZPITAL SPECJALISTYCZNY IM.S. ZEROMSKIEGO/ODDZIAL DERMATOLOGII/ OS. MLODOSCI 11 (Krakow- Poland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BENEA, MD
Organizational Affiliation
Spit Clin Dermato-Venero."Prof.Dr./Scarlat Longhin"/Calea Serban Voda216,sector4 (Bucharest- Romania)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HERRERO, MD
Organizational Affiliation
CONSULTORIO DE ALERGIA 1° PISO/HOSPITAL JUAN A. FERNANDEZ/CERVINO 3355 (Buenos Aires- Argentina)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre nº 101
City
Buenos Aires
ZIP/Postal Code
1035
Country
Argentina
Facility Name
Centre nº 105
City
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Centre nº 104
City
Buenos Aires
ZIP/Postal Code
1406
Country
Argentina
Facility Name
Centre nº 103
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Centre nº 107
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Centre nº 109
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Centre nº 108
City
Buenos Aires
ZIP/Postal Code
6500
Country
Argentina
Facility Name
Centre nº 100
City
Mar Del Plata / Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Centre nº 106
City
Rosario - Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centre nº 102
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Centre nº 202
City
Aalst
ZIP/Postal Code
3300
Country
Belgium
Facility Name
Centre nº 200
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Centre nº 201
City
Gent
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre nº 204
City
Gent
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre nº 203
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Centre nº 302
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Centre nº 305
City
Marseille cedex 9
ZIP/Postal Code
13274
Country
France
Facility Name
Centre nº 307
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Centre nº 303
City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Centre nº 308
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
Centre nº 301
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centre nº 411
City
Berlin
ZIP/Postal Code
12353
Country
Germany
Facility Name
Centre nº 404
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Centre nº 410
City
Berlin
ZIP/Postal Code
13439
Country
Germany
Facility Name
Centre nº 400
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Centre nº 407
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Centre nº 406
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Centre nº 505
City
Iwonicz Zdroj
ZIP/Postal Code
38-440
Country
Poland
Facility Name
Centre nº 507
City
Krakow
ZIP/Postal Code
31-462
Country
Poland
Facility Name
Centre nº 503
City
Krakow
ZIP/Postal Code
31-908
Country
Poland
Facility Name
Centre nº 504
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Centre nº 502
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Facility Name
Centre nº 506
City
Poznan
ZIP/Postal Code
60-631
Country
Poland
Facility Name
Centre nº 501
City
Warszawa
ZIP/Postal Code
00-891
Country
Poland
Facility Name
Centre nº 500
City
Wroclaw
ZIP/Postal Code
50-044
Country
Poland
Facility Name
Centre nº 704
City
Brasov
ZIP/Postal Code
500414
Country
Romania
Facility Name
Centre nº 700
City
Bucharest
ZIP/Postal Code
040213
Country
Romania
Facility Name
Centre nº 701
City
Bucharest
Country
Romania
Facility Name
Centre nº 702
City
Bucharest
Country
Romania
Facility Name
Centre nº 705
City
Bucharest
Country
Romania
Facility Name
Centre nº 706
City
Bucharest
Country
Romania
Facility Name
Centre nº 707
City
Bucharest
Country
Romania
Facility Name
Centre nº 703
City
Craiova Dolj
Country
Romania
Facility Name
Centre nº 804
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01004
Country
Spain
Facility Name
Centre nº 802
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Centre nº 801
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Centre nº 803
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Centre nº 805
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Centre nº 800
City
Madrid
ZIP/Postal Code
28004
Country
Spain
Facility Name
Centre nº 806
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21831011
Citation
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. Erratum In: Expert Opin Drug Saf. 2012 Jan;11(1):175.
Results Reference
background
PubMed Identifier
19860762
Citation
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.
Results Reference
result

Learn more about this trial

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

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