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Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)
This study is currently recruiting participants.
Verified by Faes Farma, S.A., March 2010
First Received: March 4, 2010   No Changes Posted
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

Resource links provided by NLM:


Further study details as provided by Faes Farma, S.A.:

Primary Outcome Measures:
  • 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: Pharmacokinetic sampling occurs on the last day of dosing (Day 7). On Day 7 (D7) dosing is given at the clinic by the investigator. ] [ 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.



Secondary Outcome Measures:
  • 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: A last Follow up visit will be performed 28 days after last drug intake ] [ 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.


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

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. Either sex aged from ≥ 2 to < 12 years of age. Female subjects must not be of child bearing potential.
  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:

  1. Female subjects of childbearing potential. If menarche occurs after study enrolment and during the dosing period, the subject should be discontinued from the treatment and followed up for safety as per protocol. Occurrence of menarche in the course of the study should always be documented.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081574

Contacts
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

Locations
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            
Sponsors and Collaborators
Faes Farma, S.A.
Investigators
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

Publications:
Jauregizar N, de la Fuente L, Lucero ML, Sologuren A, Leal N, Rodríguez M. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H(1)) effect of bilastine. Clin Pharmacokinet. 2009;48(8):543-54.
Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antépara I, Jáuregui I, Valiente R; The 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. 2009 Oct 23; [Epub ahead of print]
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. 2009 Nov 27; [Epub ahead of print]
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. 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.

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

Keywords provided by Faes Farma, S.A.:
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

Additional relevant MeSH terms:
Urticaria
Conjunctivitis, Allergic
Conjunctivitis
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 01, 2010