Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)
The conduct of this clinical trial is aimed at determining the most suitable dose regimen for children in different age groups, and secondarily to assess the safety and tolerability of bilastine in this paediatric population subset.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicentre, International, Adaptive, Open-label, Repeated Administration Pharmacokinetic Study of Bilastine in Children From 2 to <12 Years of Age With Allergic Rhinoconjunctivitis or Chronic Urticaria|
- The primary objective is to assess the pharmacokinetics of bilastine in children (aged 2 to <12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis and/or perennial allergic rhinitis [SAR/PAR]) or chronic urticaria (CU) [ Time Frame: 1 day (visit 3, Day 7) ] [ Designated as safety issue: No ]
Determination of plasma concentrations versus time (between 1 and 6 samples per subject at various time intervals after dosing according to an optimised sampling protocol) in order to perform a population pharmacokinetic analysis.
For Group A, samples of venous blood will be just prior to dose administration, and at 0.25, 0.5, 0.8, 1.0, 1.2, 1.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours after dose administration.
For Group B samples of venous blood will be just prior to dose administration, and at 0.25, 0.5, 1.0, 1.5, 3.0, 6.0, 8.0, 10.0, and 12.0 hours after dose administration.
- The secondary objectives are to describe the safety and tolerability of a repeated administration of bilastine in the aforementioned paediatric subset with allergic rhinoconjunctivitis (SAR/PAR) or chronic urticaria (CU). [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]Safety will be assessed during the study by monitoring adverse events (AEs), clinical laboratory test results (urinalysis, blood chemistry, and haematology), vital signs (including blood pressure, respiration, temperature, and heart rate, supine and standing), electrocardiogram (ECG) results, and abnormal findings upon physical examination.
|Study Start Date:||January 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: 10 mg Bilastine once daily for 7 days
10 mg Bilastine dispersible oral tablet
10 mg/qd/ 7 days.Oral dispersible tablets
Other Name: Bilaxten
The objective of this study is to assess the pharmacokinetics of bilastine in children (aged 2 to <12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis [SAR] and/or perennial allergic rhinitis [PAR]) or chronic urticaria (CU) in order to ascertain that the systemic exposure attained with a dose of 10 mg/QD or lower is comparable to that achieved in adults and adolescents administered with a dose of 20 mg/QD.
Additional objectives are to describe the safety and tolerability of a repeated administration of bilastine in children with AR or CU.
|Royal Children's Hospital|
|Parkville, Victoria, Australia, 3052|
|Australia, Western Australia|
|Princess Margaret Hospital for Children|
|Subiaco, Western Australia, Australia, 6840|
|Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie|
|Berlin, Germany, 13353|
|Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt|
|Franfurt, Germany, 60590|
|Kiel, Germany, 24105|
|Karolinska University Hospital. Astrid Lindgren's Hospital|
|Stockholm, Sweden, 17176|
|Children's Hospital at Uppsala University Hospital|
|Uppsala, Sweden, 751 85|
|Principal Investigator:||Ulrich Wahn, Prof. Dr.||International Coordinating Investigator. Charité - Universitätsmedizin Berlin (Germany)|
|Principal Investigator:||Regina Föster-Holst, Prof. Dr.||Universitäts-Hautklinik Kiel (Germany)|
|Principal Investigator:||Belén Sádaba, Dr.||Clínica Universitaria de Navarra (Spain)|
|Principal Investigator:||Gunilla Hedlin, Prof. Dr.||Karolinska University Hospital|
|Principal Investigator:||Stefan Zielen, Prof. Dr.||J.W. Goethe-Universität Frankfurt (Germany)|
|Principal Investigator:||Lennart Nordvall, Prof. Dr||Children's Hospital at Uppsala University Hospital (Sweden)|
|Principal Investigator:||Peter Le Souef, Prof. Dr.||Princess Margaret Hospital for Children (Australia)|
|Principal Investigator:||Noel E Cranswick, Prof. Dr.||Royal Children's Hospital Melbourne (Australia)|