Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)
NCT ID: NCT01081574
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2010-01-31
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Additional objectives are to describe the safety and tolerability of a repeated administration of bilastine in children with AR or CU.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
10 mg Bilastine once daily for 7 days
10 mg Bilastine dispersible oral tablet
Bilastine
10 mg/qd/ 7 days.Oral dispersible tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bilastine
10 mg/qd/ 7 days.Oral dispersible tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Height and weight within a majority range (e.g., 25th through 75th percentile) of the subject's age and sex as provided in national tables.
3. Documented history of SAR/PAR or CU at the time of inclusion. Subjects must be symptomatic at screening as judged by the investigator.
4. A documented positive skin prick test or IgE test (RAST) for at least one seasonal or perennial allergen in children with AR obtained within the 12 months prior to inclusion.
5. Excepting AR or CU, judged to be in general good health based on medical history, physical examination and clinical laboratory tests, with a QTc duration on the ECG recorded at screening within the normal range (≤ 440 msec).
6. Written informed consent signed by the legal representative of the minor (his/her parent(s) or a person legally appointed if different from parent(s)) and, where applicable, assent signed by the child, according to local regulations.
Exclusion Criteria
2. Intake of another investigational medication in another clinical study within 30 days prior to the first study drug intake.
3. Clinically significant ECG abnormalities as judged by the investigator (e.g., Wolff-Parkinson-White \[WPW\] syndrome, long QT syndrome).
4. Known allergy/hypersensitivity to the study drug or its inactive ingredients.
5. Any clinical conditions or circumstances that in the opinion of the investigator would make the subject unsuitable for the study (e.g., hepatic impairment, renal impairment, mental impairment, cardiac disease).
6. Subjects with known positive Hepatitis B surface antigen (Hbs Ag), or Hepatitis C antibody or who are known to be human immunodeficiency virus (HIV) positive. No testing will be required for this study.
7. Subjects who are expected to take during the study period or have taken any of the following medications prior to inclusion in the study and have not complied with the specified wash out period of 7 days unless otherwise noted:
* Oral corticosteroids.
* Oral antihistamines: loratadine, desloratadine, and fexofenadine.
* Anti-leukotrienes
* Amoxicillin, benzylpenicillin, and macrolide antibiotics and imidazolic antifungals (systemic)
* Omeprazol
* Aspirin, ibuprofen
* Carbamazepine
* St. John's Wort (15 days)
8. Hypersensitivity to H1 antihistamines or benzimidazoles.
9. Ingestion of citrus fruits and cranberries or any fruit juice or any other well known PgP or organic anion transporter polypeptide (OATP) inhibitor, inducer, or substrate (see Appendix C) within 7 days prior to first dose of study medication.
10. Mentally disabled minors or Minors who by official order have been institutionalised (e.g., in orphanages) must be excluded from participation.
11. Minors who explicitly refuse to take part in the study.
2 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Faes Farma, S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ulrich Wahn, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
International Coordinating Investigator. Charité - Universitätsmedizin Berlin (Germany)
Regina Föster-Holst, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitäts-Hautklinik Kiel (Germany)
Belén Sádaba, Dr.
Role: PRINCIPAL_INVESTIGATOR
Clínica Universitaria de Navarra (Spain)
Gunilla Hedlin, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Stefan Zielen, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
J.W. Goethe-Universität Frankfurt (Germany)
Lennart Nordvall, Prof. Dr
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital at Uppsala University Hospital (Sweden)
Peter Le Souef, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Hospital for Children (Australia)
Noel E Cranswick, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Royal Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Subiaco, Western Australia, Australia
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Berlin, , Germany
Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt
Franfurt, , Germany
Universitäts-Hautklinik
Kiel, , Germany
Karolinska University Hospital. Astrid Lindgren's Hospital
Stockholm, , Sweden
Children's Hospital at Uppsala University Hospital
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jauregizar N, de la Fuente L, Lucero ML, Sologuren A, Leal N, Rodriguez M. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet. 2009;48(8):543-54. doi: 10.2165/11317180-000000000-00000.
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.
Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010 May;59(5):391-8. doi: 10.1007/s00011-009-0117-4. Epub 2009 Nov 27.
Kuna P, Bachert C, Nowacki Z, van Cauwenberge P, Agache I, Fouquert L, Roger A, Sologuren A, Valiente R; Bilastine International Working Group. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clin Exp Allergy. 2009 Sep;39(9):1338-47. doi: 10.1111/j.1365-2222.2009.03257.x. Epub 2009 May 4.
Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009 Jan;64(1):158-65. doi: 10.1111/j.1398-9995.2008.01813.x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-012013-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BILA 3009/PED
Identifier Type: -
Identifier Source: org_study_id