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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01081574




Registration number
NCT01081574
Ethics application status
Date submitted
4/03/2010
Date registered
5/03/2010
Date last updated
26/09/2012

Titles & IDs
Public title
Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)
Scientific 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
Secondary ID [1] 0 0
2009-012013-22
Secondary ID [2] 0 0
BILA 3009/PED
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinoconjunctivitis 0 0
Chronic Urticaria 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Allergies
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bilastine

Experimental: 10 mg Bilastine once daily for 7 days - 10 mg Bilastine dispersible oral tablet


Treatment: Drugs: Bilastine
10 mg/qd/ 7 days.Oral dispersible tablets

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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) - 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.
Timepoint [1] 0 0
1 day (visit 3, Day 7)
Secondary outcome [1] 0 0
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). - 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.
Timepoint [1] 0 0
5 weeks

Eligibility
Key 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.
Minimum age
2 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Subiaco
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
6840 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
Germany
State/province [2] 0 0
Franfurt
Country [3] 0 0
Germany
State/province [3] 0 0
Kiel
Country [4] 0 0
Sweden
State/province [4] 0 0
Stockholm
Country [5] 0 0
Sweden
State/province [5] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Faes Farma, S.A.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01081574
Trial related presentations / publications
Jauregizar N, de la Fuente L, Lucero ML, Sologuren A, Leal N, Rodríguez 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, Antépara I, Jáuregui 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.
Public notes

Contacts
Principal investigator
Name 0 0
Ulrich Wahn, Prof. Dr.
Address 0 0
International Coordinating Investigator. Charité - Universitätsmedizin Berlin (Germany)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications