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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT01081574
First received: March 4, 2010
Last updated: September 25, 2012
Last verified: September 2012
  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 1
Phase 2

Study Type: Interventional
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

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: 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.



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: 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.


Enrollment: 36
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mg Bilastine once daily for 7 days
10 mg Bilastine dispersible oral tablet
Drug: Bilastine
10 mg/qd/ 7 days.Oral dispersible tablets
Other Name: Bilaxten

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081574

Locations
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Subiaco, Western Australia, Australia, 6840
Germany
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
Universitäts-Hautklinik
Kiel, Germany, 24105
Sweden
Karolinska University Hospital. Astrid Lindgren's Hospital
Stockholm, Sweden, 17176
Children's Hospital at Uppsala University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Faes Farma, S.A.
Investigators
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)
  More Information

Publications:

Responsible Party: Faes Farma, S.A.
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: September 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Spain: Spanish Agency of Medicines
Australia: National Health and Medical Research Council

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:
Conjunctivitis
Conjunctivitis, Allergic
Urticaria
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Vascular

ClinicalTrials.gov processed this record on November 25, 2014