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| Sponsor: | Faes Farma, S.A. |
|---|---|
| Information provided by: | Faes Farma, S.A. |
| ClinicalTrials.gov Identifier: | NCT01081574 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinoconjunctivitis Chronic Urticaria |
Drug: Bilastine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Control: Uncontrolled 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 |
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.
| Estimated Enrollment: | 44 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
10 mg Bilastine once daily for 7 days: Experimental
10 mg Bilastine dispersible oral tablet
|
Drug: Bilastine
10 mg/qd/ 7 days.Oral dispersible tablets
|
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.
Eligibility| Ages Eligible for Study: | 2 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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:
Contacts and Locations| Contact: Patricia Alonso, Manager, Clinical Research | +34 91 432 1926 | palonso@pharmanet.com |
| Contact: Ander Sologuren, Senior Investigator | +34 94 481 83 09 ext 8552 | asologur@faes.es |
| Germany | |
| Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie | Recruiting |
| Berlin, Germany, 13353 | |
| Contact: Marion Trentmann, Study Nurse -49 30 8445 4920 marion.trentmann@charite.de | |
| Principal Investigator: Ulrich Wahn, Prof. Dr. med | |
| Sub-Investigator: Philippe Stock, PD Dr. med | |
| Universitäts-Hautklinik | Recruiting |
| Kiel, Germany, 24105 | |
| Contact: Sigo Weismantel, MD +49 431 597 1579 sweissmantel@dermatology.uni-kiel.de | |
| Principal Investigator: Regina Föster-Holst, Prof. Dr. med | |
| Sub-Investigator: Sigo Weismantel, MD | |
| Sub-Investigator: Ulrike Wehkamp, Dr. med | |
| Spain, Navarra | |
| Clínica Universitaria de Navarra | Recruiting |
| Pamplona, Navarra, Spain, 31008 | |
| Contact: Andrea Manubens, MD +34 948 25 54 00 amanubens@unav.es | |
| Principal Investigator: Belén Sádaba, MD | |
| Sub-Investigator: Marta Ferrer, MD | |
| Sub-Investigator: José Ramón Azanza, MD | |
| Sweden | |
| Karolinska University Hospital. Astrid Lindgren's Hospital | Recruiting |
| Stockholm, Sweden, 17176 | |
| Contact: Björn Nordlund, Study Nurse +46 8 517 775 90 bjorn.nordlund@karolinska.se | |
| Principal Investigator: Gunilla Hedlin, Prof. Dr. med | |
| Sub-Investigator: Christophe Pedroletti, MD | |
| Sub-Investigator: Païvi Söderman, MD | |
| Principal Investigator: | Ulrich Wahn, Prof. Dr.med. | International Coordinating Investigator. Charité - Universitätsmedizin Berlin (Germany) |
| Principal Investigator: | Regina Föster-Holst, Prof. Dr. med. | Universitäts-Hautklinik Kiel (Germany) |
| Principal Investigator: | Belén Sádaba, Dr. med. | Clínica Universitaria de Navarra (Spain) |
| Principal Investigator: | Gunilla Hedlin, Prof. Dr. med | Karolinska University Hospital |
More Information
| Responsible Party: | FAES FARMA, S.A. ( Dr Ander Sologuren. Senior Investigator, Clinical Research Department ) |
| ClinicalTrials.gov Identifier: | NCT01081574 History of Changes |
| Other Study ID Numbers: | BILA 3009/PED, 2009-012013-22 |
| Study First Received: | March 4, 2010 |
| Last Updated: | March 4, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; Spain: Spanish Agency of Medicines |
|
Allergic Rhinitis Seasonal Allergic Rhinitis Perennial Allergic Rhinitis Urticaria Chronic Idiopathic Urticaria Allergy Sneezing Nasal Itching |
Rhinorrhea Nasal Congestion Wheals Hives Skin itching Flare Erythema |
|
Urticaria Conjunctivitis, Allergic Conjunctivitis Skin Diseases, Vascular Skin Diseases |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Conjunctival Diseases Eye Diseases |