UrticariaPhase 3NCT00421109
Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
A Phase 3 study testing Bilastine and Levocetirizine in people with Urticaria, run by Faes Farma, S.A. at 50 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urticaria
- What is being tested?
- Bilastine and Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 522 participants
- Where
- 50 sitesin 7 countries
- Study dates
- Jul 2006to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old.
- Documented history of CIU for at least 6 weeks prior to entry in the study.
Who cannot join
- 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
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
Argentina10 sites
Centre nº 101
Buenos Aires, 1035
Centre nº 105
Buenos Aires, 1280
Centre nº 104
Buenos Aires, 1406
Centre nº 103
Buenos Aires, 1425
Centre nº 107
Buenos Aires, 1425
Centre nº 109
Buenos Aires, 1425
Centre nº 108
Buenos Aires, 6500
Centre nº 100
Mar Del Plata / Buenos Aires, 7600
Centre nº 106
Rosario - Santa Fe, 2000
Centre nº 102
Salta, 4400
Poland8 sites
Centre nº 505
Iwonicz-Zdrój, 38-440
Centre nº 507
Krakow, 31-462
Centre nº 503
Krakow, 31-908
Centre nº 504
Lodz, 91-347
Centre nº 502
Lublin, 20-080
Centre nº 506
Poznan, 60-631
Centre nº 501
Warsaw, 00-891
Centre nº 500
Wroclaw, 50-044
Romania8 sites
Centre nº 704
Brasov, 500414
Centre nº 700
Bucharest, 040213
Centre nº 701
Bucharest
Centre nº 702
Bucharest
Centre nº 705
Bucharest
Centre nº 706
Bucharest
Centre nº 707
Bucharest
Centre nº 703
Craiova Dolj
Spain7 sites
Centre nº 802
Badalona, Barcelona, 08916
Centre nº 805
Barcelona, 08036
Centre nº 803
Bilbao, Vizcaya, 48013
Centre nº 801
Leganés, Madrid, 28911
Centre nº 800
Madrid, 28004
Centre nº 806
Valencia, 46009
Centre nº 804
Vitoria-Gasteiz, Alava, 01004
France6 sites
Centre nº 302
Lyon, 69003
Centre nº 305
Marseille, 13274
Centre nº 307
Nice, 06202
Centre nº 303
Paris, 75475
Centre nº 308
Quimper, 29000
Centre nº 301
Reims, 51092
Germany6 sites
Centre nº 411
Berlin, 12353
Centre nº 404
Berlin, 13055
Centre nº 410
Berlin, 13439
Centre nº 400
Hamburg, 20354
Centre nº 407
Hanover, 30159
Centre nº 406
Leipzig, 4103
Belgium5 sites
Centre nº 202
Aalst, 3300
Centre nº 200
Edegem, 2650
Centre nº 201
Ghent, 3000
Centre nº 204
Ghent, 3000
Centre nº 203
Kortrijk, 8500
About this 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
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.
Read the 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.
- Conditions
- Urticaria
- Being tested
- Bilastine, Levocetirizine, Placebo
- Keywords
- Urticaria, Hives, Wheals, Flare, Chronic, Idiopathic, Erythema, Skin diseases, vascular, Hypersensitivity, Immediate, Allergic, Cutaneous
- Medical subject headings
- Urticaria, Bronchiolitis Obliterans Syndrome, Erythema, Skin Diseases, Vascular, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilastineDrug
Encapsulated 20 mg Tablet. Once daily for 28 days
LevocetirizineDrug
Also called Xyzall
Encapsulated 5 mg tablet. Once daily for 28 days
PlaceboDrug
Encapsulated tablet. Once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bilastine 20 mg Receives: Drug: Bilastine |
| 2 | Active comparator | Levocetirizine 5 mg Receives: Drug: Levocetirizine |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days
Secondary outcomes (5)
Reflective and Instantaneous symptoms scores.
Measured: 28 days
QoL questionnaire.
Measured: 28 days
Overall assessment of discomfort caused by CIU.
Measured: 28 days
Investigator's overall clinical impression.
Measured: End of study
Assessment of the Impact of urticaria on the sleep scale.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJul 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- OLMOS, MD, Principal investigator, HOSP CLINICO SAN CARLOS, SERVICIO DERMATOLOGIA (Madrid- Spain)DE WEERT, MD, Principal investigator, UZ GENT/ DE PINTELAAN 185 (Belgium)DUBERTRET, MD, Principal investigator, HOPITAL ST LOUIS/SCE DERMATOLOGIE/1 AV. CLAUDE VELLEFAUX (Paris- France)SIMON, MD, Principal investigator, UNIV. KLINIKUM LEIPZIG/KLINIK FÜR DERMATOLOGIE (Germany)KAPINSKA-MROWIECKA, MD, Principal investigator, SZPITAL SPECJALISTYCZNY IM.S. ZEROMSKIEGO/ODDZIAL DERMATOLOGII/ OS. MLODOSCI 11 (Krakow- Poland)BENEA, MD, Principal investigator, Spit Clin Dermato-Venero."Prof.Dr./Scarlat Longhin"/Calea Serban Voda216,sector4 (Bucharest- Romania)HERRERO, MD, Principal investigator, CONSULTORIO DE ALERGIA 1° PISO/HOSPITAL JUAN A. FERNANDEZ/CERVINO 3355 (Buenos Aires- Argentina)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421109
- Sponsor's protocol ID
- BILA 2006/UCI
- Other IDs
- 2006-001245-33
- Status last verified
- Apr 2012
- First submitted
- 9 Jan 2007
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21831011Zuberbier 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.
PubMed 19860762
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00421109
- Acronym / sponsor ID
- BILA 2006/UCI
- Conditions
- Urticaria
- Keywords
- Urticaria, Hives, Wheals, Flare, Chronic, Idiopathic, Erythema, Skin diseases, vascular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BilastineBilastine 20 mg |
| 2 | Active comparator | Drug: LevocetirizineLevocetirizine 5 mg |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 70 years old.
- Documented history of CIU for at least 6 weeks prior to entry in the study.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BilastineEncapsulated 20 mg Tablet. Once daily for 28 days | Drug | 1 |
| LevocetirizineAlso: XyzallEncapsulated 5 mg tablet. Once daily for 28 days | Drug | 2 |
| PlaceboEncapsulated tablet. Once daily for 28 days | Drug | 3 |
Primary outcome
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
5 secondary outcomes
Reflective and Instantaneous symptoms scores.
Time frame: 28 days
QoL questionnaire.
Time frame: 28 days
Overall assessment of discomfort caused by CIU.
Time frame: 28 days
Investigator's overall clinical impression.
Time frame: End of study
Assessment of the Impact of urticaria on the sleep scale.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
- Background: PubMed 21831011Church 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.
- Results publication: PubMed 19860762Zuberbier 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.
Related trials for Urticaria
Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
RecruitingPhase 3
Donidalorsen Treatment in Children With Hereditary Angioedema
Hereditary Angioedema (HAE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OLMOS, MD principal investigator
HOSP CLINICO SAN CARLOS, SERVICIO DERMATOLOGIA (Madrid- Spain)
DE WEERT, MD principal investigator
UZ GENT/ DE PINTELAAN 185 (Belgium)
DUBERTRET, MD principal investigator
HOPITAL ST LOUIS/SCE DERMATOLOGIE/1 AV. CLAUDE VELLEFAUX (Paris- France)
50 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bilastine and Levocetirizine in people with Urticaria, run by Faes Farma, S.A. at 50 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Argentina, Poland, Romania, Spain, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421109, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2012.